Laparoscopic sacrocolpopexy is as safe in septuagenarians or elder as in younger women

Laparoscopic sacrocolpopexy is as safe in septuagenarians or elder as in younger women Background: Data concerning laparoscopic sacrocolpopexy (LSCP) in elder women are scarce. We compared intra-operative and early-postoperative complications associated with laparoscopic colpo-, cervico-, or hysteropexy in women under and above 70 years. Methods: Retrospective assessment by an independent investigator of a prospective cohort of 571 consecutive women undergoing LSCP in a tertiary unit over an 18-year period. Data included were patient demographics, operative variables, intra-operative, and early (≤ 3 months) postoperative complications. Complications were graded according to the Clavien-Dindo classification and mesh complications categorized using the International Urogynaecological Association (IUGA)-classification. Findings: Median age was 66 (IQR 15, range 27-91) and 204 (35.7%) patients were older than 70 years. There were no deaths. Strategic conversion rate was 2.3% (13/571), the majority because of extensive adhesions yet early in our experience. Reactive conversion rate was 0.7% (4/571). Among 554 patients who had a completed LSCP, there were 20 intra-operative complications (3.6%), mostly bladder (1.3%) and vaginal (1.1%) injuries. Eighty-four patients had a total of 95 early-postoperative Dindo ≥ II complications (15.1%). Most common complications were infectious and treated medically (Dindo II). Clinically major complications are rare (III = 3.1% and IV = 0.2%). Reoperation for suspected bleeding (IIIb = 0.7%) was the most common reintervention, typically without demonstrable cause. Most mesh complications were vaginal exposures. Septuagenarians were not more likely to have an intra-operative (4.0 vs 3.3% < 70 years, p = 0.686) or early-postoperative complication (13.6 vs 16.0% < 70 years, p = 0.455) than younger patients. Mesh complications were also equally uncommon. Conclusions: LSCP is as well-tolerated by women above 70 years as by younger women. Keywords: Laparoscopic sacropexy, Elder women, Elderly, Complication, Conversion, Laparoscopy Background sacrocolpopexy, the vaginal vault, cervix, or uterus is fixed Clinically visible pelvic organ prolapse (POP) occurs in up by means of a graft to the anterior longitudinal ligament to 50% of parous women, half of them being symptomatic over the sacrum. This operation conserves vaginal length; [1, 2]. When operated, most patients can be adequately hence, should not compromise its function. Historically, managed by vaginal access. In case of apical descent or a sacrocolpopexy was performed by laparotomy, competing multi-compartment prolapse yet with a so-called level-I de- with vaginal sacrospinous fixation, which has a shorter op- fect, abdominal suspension is a better approach [3]. In eration time, lower morbidity, and hospital cost, and which can be offered under loco-regional anesthesia. In the 90s, we moved towards laparoscopic sacrocolpopexy (LSCP) * Correspondence: Jan.Deprest@uzleuven.be and earlier reported on the medium term outcomes [4, 5]. Pelvic Floor Unit Department of Gynaecology, University Hospitals Leuven, Since 2012, there is level-I evidence that LSCP yields as Leuven Herestraat 49, 3000 Leuven, Belgium Institute for Women’s Health, University College London, London, UK good anatomical and subjective outcomes as the same Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 2 of 10 operation by laparotomy [6]. Moreover, it is associated with quantification system (POP-Q) [15]. Sacropexy procedures less blood loss, less pain, and a shorter hospital stay. Con- were either vault suspension (n = 419), cervicopexy (n = versely, operation time, return to normal activities, or func- 136), or hysteropexy (n = 16), according to the presence or tional effects were comparable for both modalities. More absence of the uterus and the patient’sdesiretoconserveit. recently, this operation is also performed robotically, yet The nature of concomitant pelvic floor or other surgery without any proven benefit [7]. was also noted. LSCP was performed or supervised by an Given that the population is aging and that symptom- experienced surgeon with a standardized technique and atic POP is more common among the elderly, the num- structured training program [16, 17]. Over the years, the ber of elder patients eligible for sacropexy will also only change was the replacement of non-resorbable multi- increase. In 2016, 19.2% of the EU-28-popluation was filament polyester by monofilamentary polydioxanone su- over 65 years (5.4% > 80 years), and by 2030 that will be tures, the abandoning of acellular collagen matrices, and 23.9% (7.2% > 80 years) [8]. With increased activity and increasingly lighter meshes [17, 18]. These changes were a healthier population, POP surgery in the elderly will implemented irrespective of the age of the patient. All pa- therefore increase accordingly. In one study [9], the an- tients received prophylactic antibiotics (cefazolin and nual risk for POP surgery was 4.3/1000 women aged metronidazole unless known allergies). Low molecular 71–73 years and in another one it was 5.0/1000 women weight heparin injections were given until discharge, or lon- aged 65–69 years [10]. With age, the prevalence of ger in case of a history of venous thromboembolism. Mid- chronic illnesses and comorbidities increases, including stream urine culture was taken after removal of the poor cardiopulmonary reserve, not to forget, the preva- catheter. Patients were typically reassessed within 3 months lence of prior surgery [11]. Considering that POP is not after the operation. a life-threatening condition, surgeons and anesthetists For this study, the electronic medical records were may be reluctant to perform complex and potentially screened by a physician not involved in the surgery or man- risky operations in the elderly. However, we speculated agement of the patient. She identified any planned and un- that, particularly in this population, the choice of min- planned hospital visits or any evidence of management for imally invasive surgery is beneficial, because of reduced adverse events within 12 weeks after surgery. This includes morbidity, lower transfusion rate, decreased post- visits elsewhere at a hospital using our network’selectronic operative pain, shorter hospital stay, and faster recovery medical record system. In the absence of data, the general hence quicker return to normal activity [12]. practitioner was contacted for a follow-up. Post hoc, post- The relationship between age and complication risk is operative complications were categorized using the modi- however controversial. At present, little is known on fied Clavien-Dindo surgical complication classification outcome of LSCP in the elderly. Currently available case system [19] and mesh complications by the terminology of series or cohort studies are small to medium sized (≤ the International Urogynecological Association (IUGA) 302 patients) with only one controlled study [2][13] [20]. Previous studies on rectal sacropexy considered Dindo [14]. Most studies show similar complication rates in grade III complications as clinically being relevant, hence younger and elder patients, yet occasionally higher com- severe [21]. Other data retrieved included pre-operative plication rates are observed, including for sacrocolpo- characteristics (age, body mass index, menopausal status, pexy [2]. In the latter study, age ≥ 65 years remained a diabetes, smoking habits, previous surgery), operative details significant predictor of complications after correction (operation time, estimated blood loss), and the occurrence for BMI, estimated blood loss, and operating time (ad- and nature of any intra-operative and early postoperative justed OR 2.28, 95% CI 1.21–4.29, p = 0.01). Herein, we (≤ 12 weeks) complications. Conversions were categorized aimed to determine whether in our setting there was an into either a strategic conversion, i.e., instances where the increased risk for intra- or postoperative complications surgeon as a precaution decided to open up the abdomen when LSCP is offered to the elder patient. In our unit, or to proceed vaginally, or reactive, i.e., as a result of an sacrocolpopexy is the first choice for the surgical man- intra-operative complicationwhich thesurgeon felt was agement of level I defects [5], also for elder patients who better managed through open abdomen [22, 23]. are judged to be fit for general anesthesia. Data were entered into a purpose designed database, and statistical analysis was performed using SPSS soft- Methods ware (version 24.0, IBM, Armonk, New York, USA). This is a retrospective analysis of a prospective cohort of Normality testing was done using the Kolgomorov- consecutive patients scheduled for LSCP at the University Smirnov test. Continuous data were compared using the Hospitals Leuven. Laparoscopy was the preferred route unpaired Student’s t test and categorical data using the from September 1997 onwards, and all consecutive cases χ Fisher exact two-tailed test. Our ongoing prospective till December 2015 were included. Preoperatively patients follow-up study as well as this audit was approved by were clinically assessed using the pelvic organ prolapse the ethical committee on clinical studies (MP10810). Vossaert et al. Gynecological Surgery (2018) 15:11 Page 3 of 10 Findings after > 120 min of surgery. Her sacropexy was un- Patient data eventfully completed via laparotomy. In one patient During this 18-year period, 571 consecutive patients (aged 81), a large bowel perforation occurred at the had a LSCP (Table 1). Their median age was 66.3 years time of open laparoscopy. Primary repair of the per- (range 27-91; IQR 14.5). Two hundred four (35.7%) pa- foration was done and sacropexy was uneventfully tients were above 70. Of these, 101 (17.7%) patients completed by open access, using a non-cross linked were above 75, including 26 (4.6%) above 80 and two 8-layered small intestinal submucosa graft (SIS, Cook, (0.4%) above 90 years. 73.4% underwent a LSCP after Bloomington, IN) [18]. The postoperative course was previous hysterectomy, 24.2% had a cervicopexy with uneventful. There were two additional conversions for concomitant laparoscopic-assisted subtotal hysterec- vascular injury early in the operation, one for epigas- tomy (LASH) and 2.8% had a hysteropexy. Twenty-six tric artery injury (age 44) and one left iliac vein were redo-sacropexies (4.6%). Concomitant rectopexy, laceration (age 60). In both bleeding was controlled incontinence surgery, or vaginal prolapse surgery was by open access and an uneventful open sacropexy was performed in 5.3, 3.7, and 3.0%, respectively. done. None of these patients required a blood transfusion. Overall conversion rate was similar in Conversions both age groups (11/367 = 3.0% < 70 vs 6/204 = 2.9%, The overall conversion rate was 3.0% or 17 patients with p = 0.969). In retrospect, there was an early (< 60 a median age of 68 (range 44-81; IQR 12). There were cases) peak of strategic conversions, yet thereafter 13 strategic conversions. In 11 cases, conversion was be- conversions were rare and equally distributed along cause of adhesions (1.9%; median age = 67; range 56–76; the experience (Fig. 1). These 17 patients are not fur- IQR 11); 9 were completed as open sacropexies (median ther included in statistical analysis as they did not age 67; range 56–73, IQR 11), and 2 had a vaginal undergo a complete LSCP. suspension (age 67 and 76) instead. There were two additional patients (age 68 and 72) where visualization of presacral vascular anatomy was judged problematic, Intra-operative complications without need for conversion and an uneventful open sacropexy was done. Twenty additional patients had an intra-operative There were four reactive conversions (0.7%). One complication, their nature displayed in Table 2 (20/554 = patient (age 68) was converted because of hypercapnia 3.6%). The majority were lesions to the bladder (n =10), Table 1 Patient characteristics of the cohort and operative variables for all patients broken down by age category (under and above 70 years) Median or % ≤ 70 years > 70 years Number of patients Total 571 (100%) 367 (64.3%) 204 (35.7%) Baseline patient characteristics p Age (years) 66 (IQR 15) 61 (IQR 11) 75 (IQR 6) 0.000 BMI (kg/m ) 25 (IQR 5) 25 (IQR 5) 25.5 (IQR 4) 0.917 Menopausal 90.7% 87.2% 100% 0.000 Diabetes mellitus (all types) 10.8% 9.5% 13.4% 0.344 Current smoker 12.2% 15.7% 3.9% 0.001 Prior hysterectomy 73.4% 70.3% 78.9% 0.025 Prior POP surgery 72.1% 68.9% 77.8% 0.022 Prior LSCP 4.6% 5.7% 2.5% 0.072 Nature of procedures (index operation) Sacrocolpopexy 73.4% 70.3% 78.9% 0.025 Concomitant LASH + cervicopexy 24.2% 27.0% 19.1% 0.036 Hysteropexy 2.8% 3.0% 2.5% 0.705 Concomitant rectopexy 5.3% 5.5% 4.9% 0.783 Concomitant incontinence surgery 3.7% 3.6% 3.9% 0.814 Concomitant vaginal surgery 3.0% 3.3% 2.5% 0.584 Abbreviations: BMI = body mass index, LASH = laparoscopic subtotal hysterectomy, LSCP = laparoscopic sacrocolpopexy. Absolute values not displayed; missing values range from prior surgery 0% to certitude on menopausal status 26.4% Vossaert et al. Gynecological Surgery (2018) 15:11 Page 4 of 10 Fig. 1 Effect of experience on a (blue) the number of reactive conversions, b (red) strategic conversions, and c (green) the number of intra-operative complications. X axis, number of patients in blocks of 60 [5, 16]; Y axis, absolute number of cases. The number below each block refers to the percentage of patients above 70 years vagina (n = 6), or epigastric arteries (n = 2), which were detached, fell in the abdomen, and could only be laparo- managed laparoscopically. In one patient with hypercap- scopically retrieved under fluoroscopy. nia, the operation was temporarily suspended for hyper- ventilation, yet could eventually be completed by Postoperative complications according to the Clavien-Dindo laparoscopy. She was afterwards briefly observed in the in- classification tensive care unit (ICU), which is a deviation from the nor- The follow up rate was 100%. Eighty-four women mal protocol. In one patient, a suturing needle got (84/554 = 15.2%) had in total 95 postoperative complica- tions within 3 months (Dindo grade ≥ II; Table 3). Dindo II complications are those events that cause a deviation from the normal postoperative course and that prompt Table 2 Rate and nature of complications in 554 the use of drugs other than analgesics, antipyretics, anti- consecutive patients who had their sacrocolpopexy emetics, diuretics, electrolytes, and physiotherapy. Among completely by laparoscopy these, urinary tract infection was the most common (5. Per-operative n (%) ≤ 70 years > 70 years p value complications 9%), the majority identified on urine culture and asymp- tomatic. Other common Dindo II complications were the Number of 554 356 (64.3%) 198 (36.7%) patients need for blood transfusion (1.9%) and the occurrence of Visceral injuries 16 (2.9%) 10 (2.8%) 6 (3.0%) 0.882 postoperative fever/asymptomatic CRP rise treated with antibiotics (1.9%). Dindo III and higher were categorized Bladder 7 (1.3%) 5 (1.4%) 2 (1.0%) – as major, as earlier described for rectopexy [21]. Interven- Ureter 3 (0.5%) 3 (0.8%) 0 (0.0%) – tions without the need for general anesthesia (Dindo IIIa) Vaginal 6 (1.1%) 2 (0.6%) 4 (2.0%) – were for patients with urinary retention and in one patient Vascular injury 2 (0.4%) 0 (0.0%) 2 (1.0%) 0.127 in office mesh removal and administration of intravenous Epigastric artery 2 (0.4%) 0 (0.3%) 2 (1.0%) – antibiotics, because of frank mesh extrusion and obvious bleeding local infection. She recovered completely and remained Anesthetic 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000 without any reintervention without recurrence beyond the problems observation period. Hypercapnia 1 (0.2%) 1 (0.3%) 0 (0.0%) – Reintervention under general anesthesia (Dindo IIIb), Other 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000 and ICU admission (Dindo IV) are clinically very rele- Needle detachment 1 (0.2%) 1 (0.3%) 0 (0.0%) – vant complications. These were rare (n = 13, 2.3%). There were four early second look laparoscopies for Total number 20 (3.6%) 12 (3.3%) 8 (4.0%) 0.686 suspected hemorrhage. Despite a hemoperitoneum, in Abbreviations: –, not calculated because of low number per individual cell. p values are based on χ testing (Fisher exact) none of them a true source could be identified. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 5 of 10 Table 3 Nature and number of 95 early postoperative complications in 83 patients broken down according to the Dindo classification and categorized by age groups. When several complications occurred, the patient was counted in the highest category applicable Early postoperative complications n ≤70 years > 70 years p value Number of patients 554 356 198 Number of patients with complications 84 57 27 0.455 (% of the population) (15.2%) (16.0%) (13.6%) Number of complications 95 61 34 Dindo II—any deviation from the normal postoperative course 77 53 24 0.372 requiring pharmacological treatment with drugs other than such (14.9%) (12.1%) allowed for grade I complications Antibiotics for asymptomatic or symptomatic urinary tract infection 33 24 9 Antibiotics for postoperative fever and/or CRP rise 11 9 2 Treatment of vaginal infection 4 3 1 Antibiotics for umbilical/trocar wound infection 4 4 0 Antibiotics for chronic obstructive pulmonary disease 22 0 exacerbation/pneumonia Antibiotic prophylaxis after vomiting during extubation 1 1 0 Blood transfusion 11 6 5 Administration of (additional) drugs (amlodipine, perindopril, 71 6 digoxin, bisoprolol, haloperidol) Low molecular weight heparin for treatment of deep venous 43 1 thrombosis/pulmonary embolism Dindo IIIa—complication requiring surgical, endoscopic, or 41 3 0.100 radiologic intervention not under general anesthesia (0.3%) (1.5%) Infection with mesh extrusion, vaginally removed in the office 1 0 1 Urinary retention, catheterization 3 1 2 Dindo IIIb—complication requiring surgical, endoscopic, 13 7 6 0.429 or radiologic intervention under general anesthesia (2.0%) (3.0%) Reoperation for prolapse 1 0 1 Reoperation for suspected hemorrhage 4 2 2 Reoperation for ureter reimplantation 1 1 0 Reoperation for mesh removal 2 1 1 Reoperation for exposure sling 1 1 0 Reoperation: cholecystectomy 2 2 0 Reoperation for bowel obstruction 2 0 2 Dindo IV—life-threatening complication 1 0 1 0.357 (0.0%) (0.5%) ICU admission for cardiac decompensation and 10 1 pulmonary edema Abbreviations: CRP, C-reactive protein. Statistics were done on individual patient basis for each Dindo category There were three directly prolapse surgery-related add- in remission, we performed a successful abdominal sacro- itional surgeries. One 63-year-old heavy-smoking chronic pexy 2 weeks later. She remained asymptomatic. There obstructive pulmonary disease (COPD) patient developed were two reinterventions for mesh-related complications. vault detachment when awakening with vomiting and One 60-year-old patient developed spondylodiscitis (IUGA coughing. She was reinduced to reattach the mesh to the 6CT2S4), from which she recovered after 9 weeks of anti- vault. Because of bronchitis, she was heavily coughing in biotic therapy (including 3 weeks intravenously). She later the postoperative period, leading again to recurrence. Once had a mesh exposure fixed. One 74-year-old patient Vossaert et al. Gynecological Surgery (2018) 15:11 Page 6 of 10 developed a severe pelvic infection for which the mesh was Mesh-related complications removed laparoscopically on day 6. She was postoperatively There were 15 (2.7%) mesh-related complications, includ- admitted to ICU (Dindo IV) because of severe dyspnea dis- ing some already mentioned above (Table 4). Six patients appearing with diuretics. She remained under intraven- had clinical signs of infection in the mesh area, yet four ous antibiotics for 14 days. She recovered and did not without loss of vaginal epithelial integrity (IUGA 1CT2 or develop recurrence. In retrospect, this patient had T3). These were managed by intravenous administration of multiple co-morbidities among which essential throm- antibiotics (making them Dindo II complications). Further, bocytosis, for which she was on the antitumoral agent there were two patients earlier mentioned. One was the pa- hydroxycarbamide. tient with symptomatic exposed mesh removed in the office Two patients had a reintervention for bowel ob- (3CT2), and the other one was the IUGA 6CT2S4 patients struction. One 80-year-old had bowel herniation in with spondylodiscitis. There were nine small (< 1 cm) su- an abdominal wall hernia. Another 78-year-old had a ture exposures, eight asymptomatic, and one symptomatic. laparotomy for adhesions 7 weeks postoperatively, Most were successfully managed in the outpatient clinic by requiring partial small bowel resection. Four patients suture removal. There were no graft-related urinary tract experienced complications away from the operation (category 4) or bowel (category 5) complications. field. One had a reintervention for a symptomatic sling exposure. Two patients suffered from cholecyst- Complications by age group and other patient itis for which they were operated. One patient who characteristics underwent simultaneous LASH was postoperatively Outcomes in patients under and above 70 years of age diagnosed with a ureteric obstruction at the level of are displayed in Tables 1–3. In terms of patient demo- the uterine artery and underwent reimplantation. graphics, younger patients were four times more likely Table 4 Mesh-related complications broken down according to the IUGA classification; with left and right column displaying numbers per age category (under (left) or above (right) 70). Statistics were done by age group for each IUGA CTS-category General AB C D Allcategories p value description↓/category→ per age group ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years Vaginal complications Asymptomatic Symptomatic Infection Abscess 1 No epithelial 0 0 0 0 3 1 0 0 3/356 (0.8%) 1/198 (0.5%) 1.000 separation 2 Smaller ≤ 1 cm exposure 7 1 1 0 0 0 0 0 8/356 (2.2%) 1/198 (0.5%) 0.168 3 Larger > 1 cm 0 0 0 0 0 1 0 0 0/356 (0.0%) 1/198 (0.5%) 0.357 exposure 4 Urinary tract Small intraoperative Other lower Ureteric or defect urinary tract upper urinary complication tract complication or urinary retention 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – 5 Rectal or bowel Small intraoperative Rectal injury Small or large Abscess defect or compromise bowel injury or compromise 0 0 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – 6 Skin and/or musculoskeletal Asymptomatic, Symptomatic Infection Abscess abnormal finding 0 0 0 0 1 0 0 0 1/356 (0.3%) 0/198 (0.0%) 1.000 7 Patient Bleeding Major degree of Mortality complication resuscitation or intensive care 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – Graft-related 12/356 (3.3%) 3/198 (1.5%) 0.277 Complications Vossaert et al. Gynecological Surgery (2018) 15:11 Page 7 of 10 to smoke. Elder patients were more likely to have under- Despite adequate control of the situation, the vascular gone previous pelvic floor surgery and/or hysterectomy. surgeon preferred to perform an open repair. Others Conversely, younger patients were more likely to have reported laparoscopic management of such event undergo cervico- or hysteropexy. Operating time was [25]. There was one bowel perforation diagnosed during comparable between both age groups as well as length entry by open laparoscopy, hence without clinical conse- of hospital stay. quences. In case of potential bacterial contamination, we When considering by age category, there were no do not use durable mesh as it may get permanently colo- differences in occurrence of intra-operative complications nized, yet use in that case resorbable biografts despite (Table 2). Early postoperative Dindo categories II, III, or poorer outcomes [18, 26]. The other intra-operative IV complications were not tied to age either. Because of complications, such as bladder or vaginal perforations, the low numbers in the subcategories of complications, no can easily be managed laparoscopically with no clinical detailed statistics for those were attempted. Short-term consequences. These were also frequently reported by mesh problems were also comparable in both age groups others [2, 14, 24]. Also, hypercapnia can be managed, ei- (Table 4). ther by conversion or by pausing the intervention. None When analyzing the entire data set, the only correl- of the above intra-operative complications seem to us ation with occurrence of complications was having a directly age-related neither are they are avoidable by prior hysterectomy. These patients were less likely to cautious patient selection. have a complication (RR 0.539 [0.33-0.88]). Actually, this There were also a number of severe postoperative compli- applied in particular to patients under 70, not above. cations. There was the patient with discitis, which required The other factors such as diabetes, menopausal status, prolonged use of antibiotics, yet no mesh removal. Discitis prior POP surgery, or prior sacropexy were not associ- is a debilitating complication, which may require multiple ated with an increased likelihood for complications in reinterventions. It has been tied to the use of staples or this data set. tackers, yet it has also been reported when sutures are used and after open repair [27, 28]. Discitis is uncommon so typ- Conclusions ically individual cases are reported or will only surface in In when reviewing this prospective cohort, an independ- large series. We do not see any reason why it would be age- ent researcher meticulously scrutinized the records for related. We had another severe local infectious complica- any adverse event during their hospital stay and during tion. This woman presented with clinical signs of pelvic the first three postoperative months after LSCP. The infection so we thought the mesh was infected. She was so occurrence of post-discharge complications was based sick she was admitted to ICU and underwent mesh on findings on the routine postoperative visit with us removal, after which she fully recovered. In retrospect, we (95.1%), elsewhere with a specialist or in its absence by probably underestimated her co-morbidities and could have contact with the general practitioner (4.9%). This re- offered her an alternative surgical technique. A third com- sulted in a 100% short-term follow-up rate, which is pos- plication, which was also in part infectious, was the COPD sible in a small country like Belgium. In addition, our patient with chronic cough and respiratory infection, in complication and conversion rate is comparable to what whom coughing caused early release of the vault. She was was observed in other large series [2, 24]. Therefore, we successfully reoperated (Dindo IIIb) when her respiratory think the results of our study are representative. problems were solved. We preoperatively felt she should Though the use of terms as “severe,”“major,” or have sacrocolpopexy after two earlier failed vaginal repairs. “minor” for complications is discouraged [19], the clin- There were also two obstructions, one because of adhe- ical relevance of the occurrence of what we categorized sions. Though we always peritonealize, adhesions are un- as “severe” cannot be debated, because of their potential avoidable, except when choosing a vaginal extraperitoneal life-threatening impact. There were a few severe intra- alternative, like sacrospinous fixation. Another striking operative complications, some of them leading to complication is postoperative bleeding. Though clinically reactive conversions. The most relevant ones were there was intra-abdominally convincing evidence of previ- hemorrhagic in nature. Three were epigastric bleedings, ous bleeding, we could never identify an active source. which early on in our experience still prompted a con- Postoperative hemorrhage is not the privilege of abdominal version in one, yet later such complication was easily procedures, neither is it more likely in the elderly. managed laparoscopically. Epigastric artery bleeding is This study was essentially undertaken to investigate also reported by others, yet is to some extent avoidable whether LSCP is justifiable in the elder population. In [2, 24]. We report one laceration at the inferior border our series, we did not find a higher risk in patients above of the iliac vein, a well-known and feared complication 70 years of age. This was neither the case when we took of sacropexy. That is probably the reason why we were a lower (65 years) or higher age cut off (data not shown). ready to compress the vein immediately with a swab. The same observation was made by others, though all Vossaert et al. Gynecological Surgery (2018) 15:11 Page 8 of 10 studies with another age cut off (range 65–80 years) [2, We acknowledge a number of other limitations. 13, 14]. This is also in line with observations following Though based on a large prospective cohort, it remains abdominal sacrocolpopexy [29]. Conversely, Turner et al. a retrospective audit on what eventually stays a selected observed a higher major complication rate following lap- population of women judged to be fit for general aroscopic or robotic sacrocolpopexy in women ≥ 65 years, anesthesia (hence, not the others). Retrospective studies both unadjusted (OR 1.84, 95% CI 1.02–3.35, p = 0.04), yet have the potential of underreporting. We have tried to also after adjustment for BMI, estimated blood loss (EBL) tackle this limitation, by [1] including all consecutive and operating room time (OR 2.28, 95% CI 1.21–4.29, cases; [2] having the data audited by a third person not p = 0.01). The authors were unable “to reliably attri- involved in the management of the patient [3]; in the ab- bute the increased risk in the elderly” to the particu- sence of physical postoperative visit of the patient, we larities of minimal invasive surgery in this population used the electronic medical record system used in a net- [2]. We did not correct for EBL or operating time, as work of hospitals and [4] contacted where necessary the they are dependent on concomitant surgery and be- general practitioner of the patient. The latter two in- cause EBL cannot be accurately measured. Also, BMI creased the follow-up rate from 95 to 100%, yet it is pos- was comparable in our patients with and without se- sible that a number of events may have been missed. vere complications. Also in other surgical disciplines, Another potential confounder is that quite some patients laparoscopy is the preferred access route in the eld- had concomitant procedures, which on themselves may erly, such as for cholecystectomy [30]orcolonic sur- have caused complications. We decided to assume they gery, including for cancer [31, 32]. Also rectopexy, were tied to the LSCP, which might be an overesti- which technically is very comparable to LSCP, can be mation. Conversely, we reported reactive conversions safely offered to the elderly [33]. In brief, elder pa- separately, hence did not include them in the statistics tients are in fact the ones who benefit the most of of procedures done completely by laparoscopy, as did avoiding a laparotomy. Vandendriessche et al. [34]. In order to disclose them, Our study definitely has its weaknesses. One limitation is we reported them separately in detail. genericinnatureasitisdue to the inherent limitations of Another problem is that, despite the large cohort, the ul- the used classifications systems. The Clavien-Dindo grading timate incidence of rare events limits statistical comparison system does not necessarily refer to the clinically most rele- between age groups. We therefore aggregated categories of vant complications. On the one hand, it identifies asymp- complications to reach reasonable numbers. Obviously, tomatic urinary tract infections (UTI) treated by a single these small numbers also limit the justified use of multivari- course of oral antibiotics (or any other one time used drug ate analysis for other factors than age. Further, we do not such as an antihypertensive) as a Dindo II complication. report outcomes on alternative procedures, such as sacros- Short lasting per-oral drug administration is barely consid- pinous fixation or colpocleisis, performed during the same ered as a complication by patients and physicians. More- period. This would be neither correct, as the selection cri- over, some of these complications, like UTI, are only picked teria for these procedures were not exactly the same. To up because one screens for it, hence may never be symp- finish, we realize this is only a report on short-term out- tomatic. Along the same lines, also the IUGA mesh compli- comes, yet the functional and long-term outcome of this cation system identifies asymptomatic exposures as a grade cohort is the subject of another study. 2A complication, including a suture exposure. Such com- This study has however its strengths. To our knowledge, plications are obviously clinically irrelevant, whatever the this is the largest cohort study looking into complications age of the patient. Conversely, the Dindo classification sys- with a 100% short-term follow-up rate. It is a consecutive tem underestimates relevant incidents like transient neuro- series of standardized operations at a single center, yet logical symptoms, such as sensory or motoric dysfunction with both experienced operators and subspecialists in in the lower limbs, which we tied to wrong positioning of training. Finally, the assessment was done by a clinician the patient [5]. Though they only required prolonged not involved in the surgical management of the patients. physiotherapy and other conservative measures, and even- Given that our overall outcomes fall in the range of what tually fully recovered, this is a tangible complication for is expected, we believe the conclusion of this study stands. the patient and the healthcare system. It however qualifies In conclusion, in this large prospective cohort intra- as a Dindo I complication, hence was not included here. operative and severe (Dindo III and IV), early postopera- Moreover, in the elderly any limitation in mobility is ad- tive complications occurred in 3.6 and 2.3%, respectively. versely influencing outcome. Briefly, the limitation of the Older age at the time of intervention was not associated Dindo classification is that it is based on the nature of the with additional morbidity. Therefore, we conclude that intervention prompted by the complication. In that re- LSCP appears to be well-tolerated and safe in elderly spect, the IUGA/ICS mesh-complication classification is women with level I defects and without contra-indication more patient-centered. for general anesthesia. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 9 of 10 Abbreviations 3. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J (2016) BMI: Body mass index; CI: Confidence interval; COPD: Chronic obstructive Surgery for women with apical vaginal prolapse. Cochrane Database Syst pulmonary disease; EBL: Estimated blood loss; EU-28-population: European Rev 10:CD012376 Union of the 28 countries-population; ICU: Intensive care unit; IQR: Interquartile 4. Claerhout F, De Ridder D, Roovers JP, Rommens H, Spelzini F, range; IUGA: International Urogynaecological Association; LASH: Laparoscopic- Vandenbroucke V et al (2009) Medium-term anatomic and functional results assisted subtotal hysterectomy; LSCP: Laparoscopic sacrocolpopexy; OR: Odds of laparoscopic sacrocolpopexy beyond the learning curve. Eur Urol 55(6): ratio; POP: Pelvic organ prolapse; POP-Q: Pelvic organ prolapse quantification; 1459–1467 RR: Relative risk; SPSS: Statistical Package for the Social Sciences; UTI: Urinary 5. Claerhout F, Roovers JP, Lewi P, Verguts J, De Ridder D, Deprest J (2009) tract infection Implementation of laparoscopic sacrocolpopexy–a single centre's experience. Int Urogynecol J Pelvic Floor Dysfunct 20(9):1119–1125 6. Freeman RM, Pantazis K, Thomson A, Frappell J, Bombieri L, Moran P et al Availability of data and materials (2013) A randomised controlled trial of abdominal versus laparoscopic The dataset is available with the corresponding author. sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study. Int Urogynecol J 24(3):377–384 Disclosures 7. Callewaert G, Bosteels J, Housmans S, Verguts J, Van Cleynenbreugel B, Van Our research program has previously received support from Bard, Covedien, der Aa F et al (2016) Laparoscopic versus robotic-assisted sacrocolpopexy FEG Textiltechnik, Ethicon, Blasingame and Garrard Law. All provided for pelvic organ prolapse: a systematic review. Gynecol Surg 13:115–123 unconditional grants managed by the transfer office Leuven Research and 8. http://ec.europa.eu/eurostat/statistics-explained/index.php/Population_ Development of the KU Leuven. The investigators design the protocols, are structure_and_ageing. Accessed 21 July 2017 owners of the results, and publish these independently of the above. JDP is 9. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson FM (2014) Lifetime risk a proctor for Ethicon Endosurgery in their side-by-side teaching program. of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol 123(6):1201–1206 Authors’ contributions 10. Smith FJ, Holman CD, Moorin RE, Tsokos N (2010) Lifetime risk of undergoing KV, SH, SP, GC, FVDA, AW, ADH, PR, and JDP did the clinical management of surgery for pelvic organ prolapse. Obstet Gynecol 116(5):1096–1100 the patients involved, both at the pre- and postoperative outpatient setting 11. Richardson JD, Cocanour CS, Kern JA, Garrison RN, Kirton OC, Cofer JB et al and perioperative follow-up. KV, SP, GC, and LC did the data collection. KV (2004) Perioperative risk assessment in elderly and high-risk patients. J Am and JDP did the data analysis. All authors contributed to manuscript writing, Coll Surg 199(1):133–146 read, and approved the manuscript. 12. Bates AT, Divino C (2015) Laparoscopic surgery in the elderly: a review of the literature. Aging Dis 6(2):149–155 Competing interest 13. King SW, Jefferis H, Jackson S, Marfin AG, Price N (2017) Laparoscopic We received an investigator-initiated research grant from Johnson & Johnson uterovaginal prolapse surgery in the elderly: feasibility and outcomes. for an initial audit of sacropexy patients. Both the study protocol, data Gynecol Surg 14(1):2 analysis, interpretation and reporting, as well as the manuscript were 14. Boudy AS, Thubert T, Vinchant M, Hermieu JF, Villefranque V, Deffieux X made without interference of the company. (2016) Outcomes of laparoscopic sacropexy in women over 70: a comparative study. Eur J Obstet Gynecol Reprod Biol 207:178–183 Authors’ information 15. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P et al JD was a fundamental clinical researcher for the Fonds Wetenschappelijk (1996) The standardization of terminology of female pelvic organ prolapse Onderzoek Vlaanderen (1801207) till 2015. He now is funded by the Great and pelvic floor dysfunction. Am J Obstet Gynecol 175(1):10–17 Ormond Street Hospital Charity Fund. 16. Claerhout F, Verguts J, Werbrouck E, Veldman J, Lewi P, Deprest J (2014) Analysis of the learning process for laparoscopic sacrocolpopexy: Ethics approval and consent to participate identification of challenging steps. Int Urogynecol J 25(9):1185–1191 Our ongoing prospective follow-up study as well as this audit was approved 17. Manodoro S, Werbrouck E, Veldman J, Haest K, Corona R, Claerhout F by the Ethical Committee on Clinical Studies of the UZ Leuven (MP10810), et al (2011) Laparoscopic sacrocolpopexy. Facts, views & vision in and patients gave informed consent for the prospective follow-up study. ObGyn 3(3):151–158 18. Deprest J, De Ridder D, Roovers JP, Werbrouck E, Coremans G, Claerhout F (2009) Medium term outcome of laparoscopic sacrocolpopexy with Publisher’sNote xenografts compared to synthetic grafts. J Urol 182(5):2362–2368 Springer Nature remains neutral with regard to jurisdictional claims in 19. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical published maps and institutional affiliations. complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205–213 Author details 20. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J et al Pelvic Floor Unit Department of Gynaecology, University Hospitals Leuven, (2011) An international Urogynecological association (IUGA) / international Leuven Herestraat 49, 3000 Leuven, Belgium. Department of Urology, continence society (ICS) joint terminology and classification of the University Hospitals Leuven, Leuven, Belgium. Department of Abdominal complications related directly to the insertion of prostheses (meshes, Surgery, University Hospitals Leuven, Leuven, Belgium. Departments of implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J Gastroenterology, University Hospitals Leuven, Leuven, Belgium. Academic Pelvic Floor Dysfunct 22(1):3–15 Department of Development and Regeneration, Group Biomedical Sciences, 21. Consten EC, van Iersel JJ, Verheijen PM, Broeders IA, Wolthuis AM, D'Hoore Katholieke Universiteit Leuven, Leuven, Belgium. Institute for Women’s A. Long-term outcome after laparoscopic ventral mesh rectopexy: an Health, University College London, London, UK. observational study of 919 consecutive patients. Ann Surg 2015;262(5):742-747; discussion 7-8 Received: 27 September 2017 Accepted: 8 May 2018 22. Blikkendaal MD, Twijnstra AR, Stiggelbout AM, Beerlage HP, Bemelman WA, Jansen FW (2013) Achieving consensus on the definition of conversion to laparotomy: a Delphi study among general surgeons, gynecologists, and urologists. Surg Endosc 27(12):4631–4639 References 1. Glazener C, Elders A, MacArthur C, Lancashire RJ, Herbison P, Hagen S et al 23. Twijnstra AR, Blikkendaal MD, van Zwet EW, Jansen FW (2013) Clinical (2013) Childbirth and prolapse: long-term associations with the symptoms relevance of conversion rate and its evaluation in laparoscopic hysterectomy. and objective measurement of pelvic organ prolapse. BJOG Int J Obstet J Minim Invasive Gynecol 20(1):64–72 Gynaecol 120(2):161–168 24. Vandendriessche D, Giraudet G, Lucot JP, Behal H, Cosson M (2015) Impact 2. Turner LC, Kantartzis K, Lowder JL, Shepherd JP (2014) The effect of age on of laparoscopic sacrocolpopexy learning curve on operative time, complications in women undergoing minimally invasive sacral colpopexy. perioperative complications and short term results. Eur J Obstet Gynecol Int Urogynecol J 25(9):1251–1256 Reprod Biol 191:84–89 Vossaert et al. Gynecological Surgery (2018) 15:11 Page 10 of 10 25. Jafari MD, Pigazzi A (2013) Techniques for laparoscopic repair of major intraoperative vascular injury: case reports and review of literature. Surg Endosc 27(8):3021–3027 26. Claerhout F, De Ridder D, Van Beckevoort D, Coremans G, Veldman J, Lewi P et al (2010) Sacrocolpopexy using xenogenic acellular collagen in patients at increased risk for graft-related complications. Neurourol Urodyn 29(4):563–567 27. Rajamaheswari N, Agarwal S, Seethalakshmi K (2012) Lumbosacral spondylodiscitis: an unusual complication of abdominal sacrocolpopexy. Int Urogynecol J 23(3):375–377 28. Brito LG, Giraudet G, Lucot JP, Cosson M (2015) Spondylodiscitis after sacrocolpopexy. Eur J Obstet Gynecol Reprod Biol 187:72 29. Richter HE, Goode PS, Kenton K, Brown MB, Burgio KL, Kreder K et al (2007) The effect of age on short-term outcomes after abdominal surgery for pelvic organ prolapse. J Am Geriatr Soc 55(6):857–863 30. Lill S, Rantala A, Vahlberg T, Gronroos JM (2011) Elective laparoscopic cholecystectomy: the effect of age on conversions, complications and long-term results. Dig Surg 28(3):205–209 31. Denet C, Fuks D, Cocco F, Chopinet S, Abbas M, Costea C et al (2017) Effects of age after laparoscopic right colectomy for cancer: are there any specific outcomes? Dig Liver Dis 49(5):562–567 32. Sklow B, Read T, Birnbaum E, Fry R, Age FJ (2003) Type of procedure influence the choice of patients for laparoscopic colectomy. Surg Endosc 17(6):923–929 33. Gultekin FA, Wong MT, Podevin J, Barussaud ML, Boutami M, Lehur PA et al (2015) Safety of laparoscopic ventral rectopexy in the elderly: results from a nationwide database. Dis Colon Rectum 58(3):339–343 34. Vandendriessche D, Sussfeld J, Giraudet G, Lucot JP, Behal H, Cosson M (2017) Complications and reoperations after laparoscopic sacrocolpopexy with a mean follow-up of 4 years. Int Urogynecol J 28(2):231–239 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Gynecological Surgery Springer Journals
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Medicine & Public Health; Gynecology; Minimally Invasive Surgery; Surgical Oncology; Obstetrics/Perinatology/Midwifery; Reproductive Medicine; Interventional Radiology
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Abstract

Background: Data concerning laparoscopic sacrocolpopexy (LSCP) in elder women are scarce. We compared intra-operative and early-postoperative complications associated with laparoscopic colpo-, cervico-, or hysteropexy in women under and above 70 years. Methods: Retrospective assessment by an independent investigator of a prospective cohort of 571 consecutive women undergoing LSCP in a tertiary unit over an 18-year period. Data included were patient demographics, operative variables, intra-operative, and early (≤ 3 months) postoperative complications. Complications were graded according to the Clavien-Dindo classification and mesh complications categorized using the International Urogynaecological Association (IUGA)-classification. Findings: Median age was 66 (IQR 15, range 27-91) and 204 (35.7%) patients were older than 70 years. There were no deaths. Strategic conversion rate was 2.3% (13/571), the majority because of extensive adhesions yet early in our experience. Reactive conversion rate was 0.7% (4/571). Among 554 patients who had a completed LSCP, there were 20 intra-operative complications (3.6%), mostly bladder (1.3%) and vaginal (1.1%) injuries. Eighty-four patients had a total of 95 early-postoperative Dindo ≥ II complications (15.1%). Most common complications were infectious and treated medically (Dindo II). Clinically major complications are rare (III = 3.1% and IV = 0.2%). Reoperation for suspected bleeding (IIIb = 0.7%) was the most common reintervention, typically without demonstrable cause. Most mesh complications were vaginal exposures. Septuagenarians were not more likely to have an intra-operative (4.0 vs 3.3% < 70 years, p = 0.686) or early-postoperative complication (13.6 vs 16.0% < 70 years, p = 0.455) than younger patients. Mesh complications were also equally uncommon. Conclusions: LSCP is as well-tolerated by women above 70 years as by younger women. Keywords: Laparoscopic sacropexy, Elder women, Elderly, Complication, Conversion, Laparoscopy Background sacrocolpopexy, the vaginal vault, cervix, or uterus is fixed Clinically visible pelvic organ prolapse (POP) occurs in up by means of a graft to the anterior longitudinal ligament to 50% of parous women, half of them being symptomatic over the sacrum. This operation conserves vaginal length; [1, 2]. When operated, most patients can be adequately hence, should not compromise its function. Historically, managed by vaginal access. In case of apical descent or a sacrocolpopexy was performed by laparotomy, competing multi-compartment prolapse yet with a so-called level-I de- with vaginal sacrospinous fixation, which has a shorter op- fect, abdominal suspension is a better approach [3]. In eration time, lower morbidity, and hospital cost, and which can be offered under loco-regional anesthesia. In the 90s, we moved towards laparoscopic sacrocolpopexy (LSCP) * Correspondence: Jan.Deprest@uzleuven.be and earlier reported on the medium term outcomes [4, 5]. Pelvic Floor Unit Department of Gynaecology, University Hospitals Leuven, Since 2012, there is level-I evidence that LSCP yields as Leuven Herestraat 49, 3000 Leuven, Belgium Institute for Women’s Health, University College London, London, UK good anatomical and subjective outcomes as the same Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 2 of 10 operation by laparotomy [6]. Moreover, it is associated with quantification system (POP-Q) [15]. Sacropexy procedures less blood loss, less pain, and a shorter hospital stay. Con- were either vault suspension (n = 419), cervicopexy (n = versely, operation time, return to normal activities, or func- 136), or hysteropexy (n = 16), according to the presence or tional effects were comparable for both modalities. More absence of the uterus and the patient’sdesiretoconserveit. recently, this operation is also performed robotically, yet The nature of concomitant pelvic floor or other surgery without any proven benefit [7]. was also noted. LSCP was performed or supervised by an Given that the population is aging and that symptom- experienced surgeon with a standardized technique and atic POP is more common among the elderly, the num- structured training program [16, 17]. Over the years, the ber of elder patients eligible for sacropexy will also only change was the replacement of non-resorbable multi- increase. In 2016, 19.2% of the EU-28-popluation was filament polyester by monofilamentary polydioxanone su- over 65 years (5.4% > 80 years), and by 2030 that will be tures, the abandoning of acellular collagen matrices, and 23.9% (7.2% > 80 years) [8]. With increased activity and increasingly lighter meshes [17, 18]. These changes were a healthier population, POP surgery in the elderly will implemented irrespective of the age of the patient. All pa- therefore increase accordingly. In one study [9], the an- tients received prophylactic antibiotics (cefazolin and nual risk for POP surgery was 4.3/1000 women aged metronidazole unless known allergies). Low molecular 71–73 years and in another one it was 5.0/1000 women weight heparin injections were given until discharge, or lon- aged 65–69 years [10]. With age, the prevalence of ger in case of a history of venous thromboembolism. Mid- chronic illnesses and comorbidities increases, including stream urine culture was taken after removal of the poor cardiopulmonary reserve, not to forget, the preva- catheter. Patients were typically reassessed within 3 months lence of prior surgery [11]. Considering that POP is not after the operation. a life-threatening condition, surgeons and anesthetists For this study, the electronic medical records were may be reluctant to perform complex and potentially screened by a physician not involved in the surgery or man- risky operations in the elderly. However, we speculated agement of the patient. She identified any planned and un- that, particularly in this population, the choice of min- planned hospital visits or any evidence of management for imally invasive surgery is beneficial, because of reduced adverse events within 12 weeks after surgery. This includes morbidity, lower transfusion rate, decreased post- visits elsewhere at a hospital using our network’selectronic operative pain, shorter hospital stay, and faster recovery medical record system. In the absence of data, the general hence quicker return to normal activity [12]. practitioner was contacted for a follow-up. Post hoc, post- The relationship between age and complication risk is operative complications were categorized using the modi- however controversial. At present, little is known on fied Clavien-Dindo surgical complication classification outcome of LSCP in the elderly. Currently available case system [19] and mesh complications by the terminology of series or cohort studies are small to medium sized (≤ the International Urogynecological Association (IUGA) 302 patients) with only one controlled study [2][13] [20]. Previous studies on rectal sacropexy considered Dindo [14]. Most studies show similar complication rates in grade III complications as clinically being relevant, hence younger and elder patients, yet occasionally higher com- severe [21]. Other data retrieved included pre-operative plication rates are observed, including for sacrocolpo- characteristics (age, body mass index, menopausal status, pexy [2]. In the latter study, age ≥ 65 years remained a diabetes, smoking habits, previous surgery), operative details significant predictor of complications after correction (operation time, estimated blood loss), and the occurrence for BMI, estimated blood loss, and operating time (ad- and nature of any intra-operative and early postoperative justed OR 2.28, 95% CI 1.21–4.29, p = 0.01). Herein, we (≤ 12 weeks) complications. Conversions were categorized aimed to determine whether in our setting there was an into either a strategic conversion, i.e., instances where the increased risk for intra- or postoperative complications surgeon as a precaution decided to open up the abdomen when LSCP is offered to the elder patient. In our unit, or to proceed vaginally, or reactive, i.e., as a result of an sacrocolpopexy is the first choice for the surgical man- intra-operative complicationwhich thesurgeon felt was agement of level I defects [5], also for elder patients who better managed through open abdomen [22, 23]. are judged to be fit for general anesthesia. Data were entered into a purpose designed database, and statistical analysis was performed using SPSS soft- Methods ware (version 24.0, IBM, Armonk, New York, USA). This is a retrospective analysis of a prospective cohort of Normality testing was done using the Kolgomorov- consecutive patients scheduled for LSCP at the University Smirnov test. Continuous data were compared using the Hospitals Leuven. Laparoscopy was the preferred route unpaired Student’s t test and categorical data using the from September 1997 onwards, and all consecutive cases χ Fisher exact two-tailed test. Our ongoing prospective till December 2015 were included. Preoperatively patients follow-up study as well as this audit was approved by were clinically assessed using the pelvic organ prolapse the ethical committee on clinical studies (MP10810). Vossaert et al. Gynecological Surgery (2018) 15:11 Page 3 of 10 Findings after > 120 min of surgery. Her sacropexy was un- Patient data eventfully completed via laparotomy. In one patient During this 18-year period, 571 consecutive patients (aged 81), a large bowel perforation occurred at the had a LSCP (Table 1). Their median age was 66.3 years time of open laparoscopy. Primary repair of the per- (range 27-91; IQR 14.5). Two hundred four (35.7%) pa- foration was done and sacropexy was uneventfully tients were above 70. Of these, 101 (17.7%) patients completed by open access, using a non-cross linked were above 75, including 26 (4.6%) above 80 and two 8-layered small intestinal submucosa graft (SIS, Cook, (0.4%) above 90 years. 73.4% underwent a LSCP after Bloomington, IN) [18]. The postoperative course was previous hysterectomy, 24.2% had a cervicopexy with uneventful. There were two additional conversions for concomitant laparoscopic-assisted subtotal hysterec- vascular injury early in the operation, one for epigas- tomy (LASH) and 2.8% had a hysteropexy. Twenty-six tric artery injury (age 44) and one left iliac vein were redo-sacropexies (4.6%). Concomitant rectopexy, laceration (age 60). In both bleeding was controlled incontinence surgery, or vaginal prolapse surgery was by open access and an uneventful open sacropexy was performed in 5.3, 3.7, and 3.0%, respectively. done. None of these patients required a blood transfusion. Overall conversion rate was similar in Conversions both age groups (11/367 = 3.0% < 70 vs 6/204 = 2.9%, The overall conversion rate was 3.0% or 17 patients with p = 0.969). In retrospect, there was an early (< 60 a median age of 68 (range 44-81; IQR 12). There were cases) peak of strategic conversions, yet thereafter 13 strategic conversions. In 11 cases, conversion was be- conversions were rare and equally distributed along cause of adhesions (1.9%; median age = 67; range 56–76; the experience (Fig. 1). These 17 patients are not fur- IQR 11); 9 were completed as open sacropexies (median ther included in statistical analysis as they did not age 67; range 56–73, IQR 11), and 2 had a vaginal undergo a complete LSCP. suspension (age 67 and 76) instead. There were two additional patients (age 68 and 72) where visualization of presacral vascular anatomy was judged problematic, Intra-operative complications without need for conversion and an uneventful open sacropexy was done. Twenty additional patients had an intra-operative There were four reactive conversions (0.7%). One complication, their nature displayed in Table 2 (20/554 = patient (age 68) was converted because of hypercapnia 3.6%). The majority were lesions to the bladder (n =10), Table 1 Patient characteristics of the cohort and operative variables for all patients broken down by age category (under and above 70 years) Median or % ≤ 70 years > 70 years Number of patients Total 571 (100%) 367 (64.3%) 204 (35.7%) Baseline patient characteristics p Age (years) 66 (IQR 15) 61 (IQR 11) 75 (IQR 6) 0.000 BMI (kg/m ) 25 (IQR 5) 25 (IQR 5) 25.5 (IQR 4) 0.917 Menopausal 90.7% 87.2% 100% 0.000 Diabetes mellitus (all types) 10.8% 9.5% 13.4% 0.344 Current smoker 12.2% 15.7% 3.9% 0.001 Prior hysterectomy 73.4% 70.3% 78.9% 0.025 Prior POP surgery 72.1% 68.9% 77.8% 0.022 Prior LSCP 4.6% 5.7% 2.5% 0.072 Nature of procedures (index operation) Sacrocolpopexy 73.4% 70.3% 78.9% 0.025 Concomitant LASH + cervicopexy 24.2% 27.0% 19.1% 0.036 Hysteropexy 2.8% 3.0% 2.5% 0.705 Concomitant rectopexy 5.3% 5.5% 4.9% 0.783 Concomitant incontinence surgery 3.7% 3.6% 3.9% 0.814 Concomitant vaginal surgery 3.0% 3.3% 2.5% 0.584 Abbreviations: BMI = body mass index, LASH = laparoscopic subtotal hysterectomy, LSCP = laparoscopic sacrocolpopexy. Absolute values not displayed; missing values range from prior surgery 0% to certitude on menopausal status 26.4% Vossaert et al. Gynecological Surgery (2018) 15:11 Page 4 of 10 Fig. 1 Effect of experience on a (blue) the number of reactive conversions, b (red) strategic conversions, and c (green) the number of intra-operative complications. X axis, number of patients in blocks of 60 [5, 16]; Y axis, absolute number of cases. The number below each block refers to the percentage of patients above 70 years vagina (n = 6), or epigastric arteries (n = 2), which were detached, fell in the abdomen, and could only be laparo- managed laparoscopically. In one patient with hypercap- scopically retrieved under fluoroscopy. nia, the operation was temporarily suspended for hyper- ventilation, yet could eventually be completed by Postoperative complications according to the Clavien-Dindo laparoscopy. She was afterwards briefly observed in the in- classification tensive care unit (ICU), which is a deviation from the nor- The follow up rate was 100%. Eighty-four women mal protocol. In one patient, a suturing needle got (84/554 = 15.2%) had in total 95 postoperative complica- tions within 3 months (Dindo grade ≥ II; Table 3). Dindo II complications are those events that cause a deviation from the normal postoperative course and that prompt Table 2 Rate and nature of complications in 554 the use of drugs other than analgesics, antipyretics, anti- consecutive patients who had their sacrocolpopexy emetics, diuretics, electrolytes, and physiotherapy. Among completely by laparoscopy these, urinary tract infection was the most common (5. Per-operative n (%) ≤ 70 years > 70 years p value complications 9%), the majority identified on urine culture and asymp- tomatic. Other common Dindo II complications were the Number of 554 356 (64.3%) 198 (36.7%) patients need for blood transfusion (1.9%) and the occurrence of Visceral injuries 16 (2.9%) 10 (2.8%) 6 (3.0%) 0.882 postoperative fever/asymptomatic CRP rise treated with antibiotics (1.9%). Dindo III and higher were categorized Bladder 7 (1.3%) 5 (1.4%) 2 (1.0%) – as major, as earlier described for rectopexy [21]. Interven- Ureter 3 (0.5%) 3 (0.8%) 0 (0.0%) – tions without the need for general anesthesia (Dindo IIIa) Vaginal 6 (1.1%) 2 (0.6%) 4 (2.0%) – were for patients with urinary retention and in one patient Vascular injury 2 (0.4%) 0 (0.0%) 2 (1.0%) 0.127 in office mesh removal and administration of intravenous Epigastric artery 2 (0.4%) 0 (0.3%) 2 (1.0%) – antibiotics, because of frank mesh extrusion and obvious bleeding local infection. She recovered completely and remained Anesthetic 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000 without any reintervention without recurrence beyond the problems observation period. Hypercapnia 1 (0.2%) 1 (0.3%) 0 (0.0%) – Reintervention under general anesthesia (Dindo IIIb), Other 1 (0.2%) 1 (0.3%) 0 (0.0%) 1.000 and ICU admission (Dindo IV) are clinically very rele- Needle detachment 1 (0.2%) 1 (0.3%) 0 (0.0%) – vant complications. These were rare (n = 13, 2.3%). There were four early second look laparoscopies for Total number 20 (3.6%) 12 (3.3%) 8 (4.0%) 0.686 suspected hemorrhage. Despite a hemoperitoneum, in Abbreviations: –, not calculated because of low number per individual cell. p values are based on χ testing (Fisher exact) none of them a true source could be identified. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 5 of 10 Table 3 Nature and number of 95 early postoperative complications in 83 patients broken down according to the Dindo classification and categorized by age groups. When several complications occurred, the patient was counted in the highest category applicable Early postoperative complications n ≤70 years > 70 years p value Number of patients 554 356 198 Number of patients with complications 84 57 27 0.455 (% of the population) (15.2%) (16.0%) (13.6%) Number of complications 95 61 34 Dindo II—any deviation from the normal postoperative course 77 53 24 0.372 requiring pharmacological treatment with drugs other than such (14.9%) (12.1%) allowed for grade I complications Antibiotics for asymptomatic or symptomatic urinary tract infection 33 24 9 Antibiotics for postoperative fever and/or CRP rise 11 9 2 Treatment of vaginal infection 4 3 1 Antibiotics for umbilical/trocar wound infection 4 4 0 Antibiotics for chronic obstructive pulmonary disease 22 0 exacerbation/pneumonia Antibiotic prophylaxis after vomiting during extubation 1 1 0 Blood transfusion 11 6 5 Administration of (additional) drugs (amlodipine, perindopril, 71 6 digoxin, bisoprolol, haloperidol) Low molecular weight heparin for treatment of deep venous 43 1 thrombosis/pulmonary embolism Dindo IIIa—complication requiring surgical, endoscopic, or 41 3 0.100 radiologic intervention not under general anesthesia (0.3%) (1.5%) Infection with mesh extrusion, vaginally removed in the office 1 0 1 Urinary retention, catheterization 3 1 2 Dindo IIIb—complication requiring surgical, endoscopic, 13 7 6 0.429 or radiologic intervention under general anesthesia (2.0%) (3.0%) Reoperation for prolapse 1 0 1 Reoperation for suspected hemorrhage 4 2 2 Reoperation for ureter reimplantation 1 1 0 Reoperation for mesh removal 2 1 1 Reoperation for exposure sling 1 1 0 Reoperation: cholecystectomy 2 2 0 Reoperation for bowel obstruction 2 0 2 Dindo IV—life-threatening complication 1 0 1 0.357 (0.0%) (0.5%) ICU admission for cardiac decompensation and 10 1 pulmonary edema Abbreviations: CRP, C-reactive protein. Statistics were done on individual patient basis for each Dindo category There were three directly prolapse surgery-related add- in remission, we performed a successful abdominal sacro- itional surgeries. One 63-year-old heavy-smoking chronic pexy 2 weeks later. She remained asymptomatic. There obstructive pulmonary disease (COPD) patient developed were two reinterventions for mesh-related complications. vault detachment when awakening with vomiting and One 60-year-old patient developed spondylodiscitis (IUGA coughing. She was reinduced to reattach the mesh to the 6CT2S4), from which she recovered after 9 weeks of anti- vault. Because of bronchitis, she was heavily coughing in biotic therapy (including 3 weeks intravenously). She later the postoperative period, leading again to recurrence. Once had a mesh exposure fixed. One 74-year-old patient Vossaert et al. Gynecological Surgery (2018) 15:11 Page 6 of 10 developed a severe pelvic infection for which the mesh was Mesh-related complications removed laparoscopically on day 6. She was postoperatively There were 15 (2.7%) mesh-related complications, includ- admitted to ICU (Dindo IV) because of severe dyspnea dis- ing some already mentioned above (Table 4). Six patients appearing with diuretics. She remained under intraven- had clinical signs of infection in the mesh area, yet four ous antibiotics for 14 days. She recovered and did not without loss of vaginal epithelial integrity (IUGA 1CT2 or develop recurrence. In retrospect, this patient had T3). These were managed by intravenous administration of multiple co-morbidities among which essential throm- antibiotics (making them Dindo II complications). Further, bocytosis, for which she was on the antitumoral agent there were two patients earlier mentioned. One was the pa- hydroxycarbamide. tient with symptomatic exposed mesh removed in the office Two patients had a reintervention for bowel ob- (3CT2), and the other one was the IUGA 6CT2S4 patients struction. One 80-year-old had bowel herniation in with spondylodiscitis. There were nine small (< 1 cm) su- an abdominal wall hernia. Another 78-year-old had a ture exposures, eight asymptomatic, and one symptomatic. laparotomy for adhesions 7 weeks postoperatively, Most were successfully managed in the outpatient clinic by requiring partial small bowel resection. Four patients suture removal. There were no graft-related urinary tract experienced complications away from the operation (category 4) or bowel (category 5) complications. field. One had a reintervention for a symptomatic sling exposure. Two patients suffered from cholecyst- Complications by age group and other patient itis for which they were operated. One patient who characteristics underwent simultaneous LASH was postoperatively Outcomes in patients under and above 70 years of age diagnosed with a ureteric obstruction at the level of are displayed in Tables 1–3. In terms of patient demo- the uterine artery and underwent reimplantation. graphics, younger patients were four times more likely Table 4 Mesh-related complications broken down according to the IUGA classification; with left and right column displaying numbers per age category (under (left) or above (right) 70). Statistics were done by age group for each IUGA CTS-category General AB C D Allcategories p value description↓/category→ per age group ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years ≤70 years > 70 years Vaginal complications Asymptomatic Symptomatic Infection Abscess 1 No epithelial 0 0 0 0 3 1 0 0 3/356 (0.8%) 1/198 (0.5%) 1.000 separation 2 Smaller ≤ 1 cm exposure 7 1 1 0 0 0 0 0 8/356 (2.2%) 1/198 (0.5%) 0.168 3 Larger > 1 cm 0 0 0 0 0 1 0 0 0/356 (0.0%) 1/198 (0.5%) 0.357 exposure 4 Urinary tract Small intraoperative Other lower Ureteric or defect urinary tract upper urinary complication tract complication or urinary retention 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – 5 Rectal or bowel Small intraoperative Rectal injury Small or large Abscess defect or compromise bowel injury or compromise 0 0 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – 6 Skin and/or musculoskeletal Asymptomatic, Symptomatic Infection Abscess abnormal finding 0 0 0 0 1 0 0 0 1/356 (0.3%) 0/198 (0.0%) 1.000 7 Patient Bleeding Major degree of Mortality complication resuscitation or intensive care 0 0 0 0 0 0 0/356 (0.0%) 0/198 (0.0%) – Graft-related 12/356 (3.3%) 3/198 (1.5%) 0.277 Complications Vossaert et al. Gynecological Surgery (2018) 15:11 Page 7 of 10 to smoke. Elder patients were more likely to have under- Despite adequate control of the situation, the vascular gone previous pelvic floor surgery and/or hysterectomy. surgeon preferred to perform an open repair. Others Conversely, younger patients were more likely to have reported laparoscopic management of such event undergo cervico- or hysteropexy. Operating time was [25]. There was one bowel perforation diagnosed during comparable between both age groups as well as length entry by open laparoscopy, hence without clinical conse- of hospital stay. quences. In case of potential bacterial contamination, we When considering by age category, there were no do not use durable mesh as it may get permanently colo- differences in occurrence of intra-operative complications nized, yet use in that case resorbable biografts despite (Table 2). Early postoperative Dindo categories II, III, or poorer outcomes [18, 26]. The other intra-operative IV complications were not tied to age either. Because of complications, such as bladder or vaginal perforations, the low numbers in the subcategories of complications, no can easily be managed laparoscopically with no clinical detailed statistics for those were attempted. Short-term consequences. These were also frequently reported by mesh problems were also comparable in both age groups others [2, 14, 24]. Also, hypercapnia can be managed, ei- (Table 4). ther by conversion or by pausing the intervention. None When analyzing the entire data set, the only correl- of the above intra-operative complications seem to us ation with occurrence of complications was having a directly age-related neither are they are avoidable by prior hysterectomy. These patients were less likely to cautious patient selection. have a complication (RR 0.539 [0.33-0.88]). Actually, this There were also a number of severe postoperative compli- applied in particular to patients under 70, not above. cations. There was the patient with discitis, which required The other factors such as diabetes, menopausal status, prolonged use of antibiotics, yet no mesh removal. Discitis prior POP surgery, or prior sacropexy were not associ- is a debilitating complication, which may require multiple ated with an increased likelihood for complications in reinterventions. It has been tied to the use of staples or this data set. tackers, yet it has also been reported when sutures are used and after open repair [27, 28]. Discitis is uncommon so typ- Conclusions ically individual cases are reported or will only surface in In when reviewing this prospective cohort, an independ- large series. We do not see any reason why it would be age- ent researcher meticulously scrutinized the records for related. We had another severe local infectious complica- any adverse event during their hospital stay and during tion. This woman presented with clinical signs of pelvic the first three postoperative months after LSCP. The infection so we thought the mesh was infected. She was so occurrence of post-discharge complications was based sick she was admitted to ICU and underwent mesh on findings on the routine postoperative visit with us removal, after which she fully recovered. In retrospect, we (95.1%), elsewhere with a specialist or in its absence by probably underestimated her co-morbidities and could have contact with the general practitioner (4.9%). This re- offered her an alternative surgical technique. A third com- sulted in a 100% short-term follow-up rate, which is pos- plication, which was also in part infectious, was the COPD sible in a small country like Belgium. In addition, our patient with chronic cough and respiratory infection, in complication and conversion rate is comparable to what whom coughing caused early release of the vault. She was was observed in other large series [2, 24]. Therefore, we successfully reoperated (Dindo IIIb) when her respiratory think the results of our study are representative. problems were solved. We preoperatively felt she should Though the use of terms as “severe,”“major,” or have sacrocolpopexy after two earlier failed vaginal repairs. “minor” for complications is discouraged [19], the clin- There were also two obstructions, one because of adhe- ical relevance of the occurrence of what we categorized sions. Though we always peritonealize, adhesions are un- as “severe” cannot be debated, because of their potential avoidable, except when choosing a vaginal extraperitoneal life-threatening impact. There were a few severe intra- alternative, like sacrospinous fixation. Another striking operative complications, some of them leading to complication is postoperative bleeding. Though clinically reactive conversions. The most relevant ones were there was intra-abdominally convincing evidence of previ- hemorrhagic in nature. Three were epigastric bleedings, ous bleeding, we could never identify an active source. which early on in our experience still prompted a con- Postoperative hemorrhage is not the privilege of abdominal version in one, yet later such complication was easily procedures, neither is it more likely in the elderly. managed laparoscopically. Epigastric artery bleeding is This study was essentially undertaken to investigate also reported by others, yet is to some extent avoidable whether LSCP is justifiable in the elder population. In [2, 24]. We report one laceration at the inferior border our series, we did not find a higher risk in patients above of the iliac vein, a well-known and feared complication 70 years of age. This was neither the case when we took of sacropexy. That is probably the reason why we were a lower (65 years) or higher age cut off (data not shown). ready to compress the vein immediately with a swab. The same observation was made by others, though all Vossaert et al. Gynecological Surgery (2018) 15:11 Page 8 of 10 studies with another age cut off (range 65–80 years) [2, We acknowledge a number of other limitations. 13, 14]. This is also in line with observations following Though based on a large prospective cohort, it remains abdominal sacrocolpopexy [29]. Conversely, Turner et al. a retrospective audit on what eventually stays a selected observed a higher major complication rate following lap- population of women judged to be fit for general aroscopic or robotic sacrocolpopexy in women ≥ 65 years, anesthesia (hence, not the others). Retrospective studies both unadjusted (OR 1.84, 95% CI 1.02–3.35, p = 0.04), yet have the potential of underreporting. We have tried to also after adjustment for BMI, estimated blood loss (EBL) tackle this limitation, by [1] including all consecutive and operating room time (OR 2.28, 95% CI 1.21–4.29, cases; [2] having the data audited by a third person not p = 0.01). The authors were unable “to reliably attri- involved in the management of the patient [3]; in the ab- bute the increased risk in the elderly” to the particu- sence of physical postoperative visit of the patient, we larities of minimal invasive surgery in this population used the electronic medical record system used in a net- [2]. We did not correct for EBL or operating time, as work of hospitals and [4] contacted where necessary the they are dependent on concomitant surgery and be- general practitioner of the patient. The latter two in- cause EBL cannot be accurately measured. Also, BMI creased the follow-up rate from 95 to 100%, yet it is pos- was comparable in our patients with and without se- sible that a number of events may have been missed. vere complications. Also in other surgical disciplines, Another potential confounder is that quite some patients laparoscopy is the preferred access route in the eld- had concomitant procedures, which on themselves may erly, such as for cholecystectomy [30]orcolonic sur- have caused complications. We decided to assume they gery, including for cancer [31, 32]. Also rectopexy, were tied to the LSCP, which might be an overesti- which technically is very comparable to LSCP, can be mation. Conversely, we reported reactive conversions safely offered to the elderly [33]. In brief, elder pa- separately, hence did not include them in the statistics tients are in fact the ones who benefit the most of of procedures done completely by laparoscopy, as did avoiding a laparotomy. Vandendriessche et al. [34]. In order to disclose them, Our study definitely has its weaknesses. One limitation is we reported them separately in detail. genericinnatureasitisdue to the inherent limitations of Another problem is that, despite the large cohort, the ul- the used classifications systems. The Clavien-Dindo grading timate incidence of rare events limits statistical comparison system does not necessarily refer to the clinically most rele- between age groups. We therefore aggregated categories of vant complications. On the one hand, it identifies asymp- complications to reach reasonable numbers. Obviously, tomatic urinary tract infections (UTI) treated by a single these small numbers also limit the justified use of multivari- course of oral antibiotics (or any other one time used drug ate analysis for other factors than age. Further, we do not such as an antihypertensive) as a Dindo II complication. report outcomes on alternative procedures, such as sacros- Short lasting per-oral drug administration is barely consid- pinous fixation or colpocleisis, performed during the same ered as a complication by patients and physicians. More- period. This would be neither correct, as the selection cri- over, some of these complications, like UTI, are only picked teria for these procedures were not exactly the same. To up because one screens for it, hence may never be symp- finish, we realize this is only a report on short-term out- tomatic. Along the same lines, also the IUGA mesh compli- comes, yet the functional and long-term outcome of this cation system identifies asymptomatic exposures as a grade cohort is the subject of another study. 2A complication, including a suture exposure. Such com- This study has however its strengths. To our knowledge, plications are obviously clinically irrelevant, whatever the this is the largest cohort study looking into complications age of the patient. Conversely, the Dindo classification sys- with a 100% short-term follow-up rate. It is a consecutive tem underestimates relevant incidents like transient neuro- series of standardized operations at a single center, yet logical symptoms, such as sensory or motoric dysfunction with both experienced operators and subspecialists in in the lower limbs, which we tied to wrong positioning of training. Finally, the assessment was done by a clinician the patient [5]. Though they only required prolonged not involved in the surgical management of the patients. physiotherapy and other conservative measures, and even- Given that our overall outcomes fall in the range of what tually fully recovered, this is a tangible complication for is expected, we believe the conclusion of this study stands. the patient and the healthcare system. It however qualifies In conclusion, in this large prospective cohort intra- as a Dindo I complication, hence was not included here. operative and severe (Dindo III and IV), early postopera- Moreover, in the elderly any limitation in mobility is ad- tive complications occurred in 3.6 and 2.3%, respectively. versely influencing outcome. Briefly, the limitation of the Older age at the time of intervention was not associated Dindo classification is that it is based on the nature of the with additional morbidity. Therefore, we conclude that intervention prompted by the complication. In that re- LSCP appears to be well-tolerated and safe in elderly spect, the IUGA/ICS mesh-complication classification is women with level I defects and without contra-indication more patient-centered. for general anesthesia. Vossaert et al. Gynecological Surgery (2018) 15:11 Page 9 of 10 Abbreviations 3. Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J (2016) BMI: Body mass index; CI: Confidence interval; COPD: Chronic obstructive Surgery for women with apical vaginal prolapse. Cochrane Database Syst pulmonary disease; EBL: Estimated blood loss; EU-28-population: European Rev 10:CD012376 Union of the 28 countries-population; ICU: Intensive care unit; IQR: Interquartile 4. Claerhout F, De Ridder D, Roovers JP, Rommens H, Spelzini F, range; IUGA: International Urogynaecological Association; LASH: Laparoscopic- Vandenbroucke V et al (2009) Medium-term anatomic and functional results assisted subtotal hysterectomy; LSCP: Laparoscopic sacrocolpopexy; OR: Odds of laparoscopic sacrocolpopexy beyond the learning curve. Eur Urol 55(6): ratio; POP: Pelvic organ prolapse; POP-Q: Pelvic organ prolapse quantification; 1459–1467 RR: Relative risk; SPSS: Statistical Package for the Social Sciences; UTI: Urinary 5. Claerhout F, Roovers JP, Lewi P, Verguts J, De Ridder D, Deprest J (2009) tract infection Implementation of laparoscopic sacrocolpopexy–a single centre's experience. Int Urogynecol J Pelvic Floor Dysfunct 20(9):1119–1125 6. Freeman RM, Pantazis K, Thomson A, Frappell J, Bombieri L, Moran P et al Availability of data and materials (2013) A randomised controlled trial of abdominal versus laparoscopic The dataset is available with the corresponding author. sacrocolpopexy for the treatment of post-hysterectomy vaginal vault prolapse: LAS study. Int Urogynecol J 24(3):377–384 Disclosures 7. Callewaert G, Bosteels J, Housmans S, Verguts J, Van Cleynenbreugel B, Van Our research program has previously received support from Bard, Covedien, der Aa F et al (2016) Laparoscopic versus robotic-assisted sacrocolpopexy FEG Textiltechnik, Ethicon, Blasingame and Garrard Law. All provided for pelvic organ prolapse: a systematic review. Gynecol Surg 13:115–123 unconditional grants managed by the transfer office Leuven Research and 8. http://ec.europa.eu/eurostat/statistics-explained/index.php/Population_ Development of the KU Leuven. The investigators design the protocols, are structure_and_ageing. Accessed 21 July 2017 owners of the results, and publish these independently of the above. JDP is 9. Wu JM, Matthews CA, Conover MM, Pate V, Jonsson FM (2014) Lifetime risk a proctor for Ethicon Endosurgery in their side-by-side teaching program. of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol 123(6):1201–1206 Authors’ contributions 10. Smith FJ, Holman CD, Moorin RE, Tsokos N (2010) Lifetime risk of undergoing KV, SH, SP, GC, FVDA, AW, ADH, PR, and JDP did the clinical management of surgery for pelvic organ prolapse. Obstet Gynecol 116(5):1096–1100 the patients involved, both at the pre- and postoperative outpatient setting 11. Richardson JD, Cocanour CS, Kern JA, Garrison RN, Kirton OC, Cofer JB et al and perioperative follow-up. KV, SP, GC, and LC did the data collection. KV (2004) Perioperative risk assessment in elderly and high-risk patients. J Am and JDP did the data analysis. All authors contributed to manuscript writing, Coll Surg 199(1):133–146 read, and approved the manuscript. 12. Bates AT, Divino C (2015) Laparoscopic surgery in the elderly: a review of the literature. Aging Dis 6(2):149–155 Competing interest 13. King SW, Jefferis H, Jackson S, Marfin AG, Price N (2017) Laparoscopic We received an investigator-initiated research grant from Johnson & Johnson uterovaginal prolapse surgery in the elderly: feasibility and outcomes. for an initial audit of sacropexy patients. Both the study protocol, data Gynecol Surg 14(1):2 analysis, interpretation and reporting, as well as the manuscript were 14. Boudy AS, Thubert T, Vinchant M, Hermieu JF, Villefranque V, Deffieux X made without interference of the company. (2016) Outcomes of laparoscopic sacropexy in women over 70: a comparative study. Eur J Obstet Gynecol Reprod Biol 207:178–183 Authors’ information 15. Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P et al JD was a fundamental clinical researcher for the Fonds Wetenschappelijk (1996) The standardization of terminology of female pelvic organ prolapse Onderzoek Vlaanderen (1801207) till 2015. He now is funded by the Great and pelvic floor dysfunction. Am J Obstet Gynecol 175(1):10–17 Ormond Street Hospital Charity Fund. 16. Claerhout F, Verguts J, Werbrouck E, Veldman J, Lewi P, Deprest J (2014) Analysis of the learning process for laparoscopic sacrocolpopexy: Ethics approval and consent to participate identification of challenging steps. Int Urogynecol J 25(9):1185–1191 Our ongoing prospective follow-up study as well as this audit was approved 17. Manodoro S, Werbrouck E, Veldman J, Haest K, Corona R, Claerhout F by the Ethical Committee on Clinical Studies of the UZ Leuven (MP10810), et al (2011) Laparoscopic sacrocolpopexy. Facts, views & vision in and patients gave informed consent for the prospective follow-up study. ObGyn 3(3):151–158 18. Deprest J, De Ridder D, Roovers JP, Werbrouck E, Coremans G, Claerhout F (2009) Medium term outcome of laparoscopic sacrocolpopexy with Publisher’sNote xenografts compared to synthetic grafts. J Urol 182(5):2362–2368 Springer Nature remains neutral with regard to jurisdictional claims in 19. Dindo D, Demartines N, Clavien PA (2004) Classification of surgical published maps and institutional affiliations. complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205–213 Author details 20. Haylen BT, Freeman RM, Swift SE, Cosson M, Davila GW, Deprest J et al Pelvic Floor Unit Department of Gynaecology, University Hospitals Leuven, (2011) An international Urogynecological association (IUGA) / international Leuven Herestraat 49, 3000 Leuven, Belgium. Department of Urology, continence society (ICS) joint terminology and classification of the University Hospitals Leuven, Leuven, Belgium. Department of Abdominal complications related directly to the insertion of prostheses (meshes, Surgery, University Hospitals Leuven, Leuven, Belgium. Departments of implants, tapes) and grafts in female pelvic floor surgery. Int Urogynecol J Gastroenterology, University Hospitals Leuven, Leuven, Belgium. Academic Pelvic Floor Dysfunct 22(1):3–15 Department of Development and Regeneration, Group Biomedical Sciences, 21. Consten EC, van Iersel JJ, Verheijen PM, Broeders IA, Wolthuis AM, D'Hoore Katholieke Universiteit Leuven, Leuven, Belgium. Institute for Women’s A. Long-term outcome after laparoscopic ventral mesh rectopexy: an Health, University College London, London, UK. observational study of 919 consecutive patients. Ann Surg 2015;262(5):742-747; discussion 7-8 Received: 27 September 2017 Accepted: 8 May 2018 22. Blikkendaal MD, Twijnstra AR, Stiggelbout AM, Beerlage HP, Bemelman WA, Jansen FW (2013) Achieving consensus on the definition of conversion to laparotomy: a Delphi study among general surgeons, gynecologists, and urologists. Surg Endosc 27(12):4631–4639 References 1. Glazener C, Elders A, MacArthur C, Lancashire RJ, Herbison P, Hagen S et al 23. Twijnstra AR, Blikkendaal MD, van Zwet EW, Jansen FW (2013) Clinical (2013) Childbirth and prolapse: long-term associations with the symptoms relevance of conversion rate and its evaluation in laparoscopic hysterectomy. and objective measurement of pelvic organ prolapse. BJOG Int J Obstet J Minim Invasive Gynecol 20(1):64–72 Gynaecol 120(2):161–168 24. Vandendriessche D, Giraudet G, Lucot JP, Behal H, Cosson M (2015) Impact 2. Turner LC, Kantartzis K, Lowder JL, Shepherd JP (2014) The effect of age on of laparoscopic sacrocolpopexy learning curve on operative time, complications in women undergoing minimally invasive sacral colpopexy. perioperative complications and short term results. Eur J Obstet Gynecol Int Urogynecol J 25(9):1251–1256 Reprod Biol 191:84–89 Vossaert et al. Gynecological Surgery (2018) 15:11 Page 10 of 10 25. Jafari MD, Pigazzi A (2013) Techniques for laparoscopic repair of major intraoperative vascular injury: case reports and review of literature. Surg Endosc 27(8):3021–3027 26. Claerhout F, De Ridder D, Van Beckevoort D, Coremans G, Veldman J, Lewi P et al (2010) Sacrocolpopexy using xenogenic acellular collagen in patients at increased risk for graft-related complications. Neurourol Urodyn 29(4):563–567 27. 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Sklow B, Read T, Birnbaum E, Fry R, Age FJ (2003) Type of procedure influence the choice of patients for laparoscopic colectomy. Surg Endosc 17(6):923–929 33. Gultekin FA, Wong MT, Podevin J, Barussaud ML, Boutami M, Lehur PA et al (2015) Safety of laparoscopic ventral rectopexy in the elderly: results from a nationwide database. Dis Colon Rectum 58(3):339–343 34. Vandendriessche D, Sussfeld J, Giraudet G, Lucot JP, Behal H, Cosson M (2017) Complications and reoperations after laparoscopic sacrocolpopexy with a mean follow-up of 4 years. Int Urogynecol J 28(2):231–239

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Gynecological SurgerySpringer Journals

Published: Jun 5, 2018

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