Has Shouldice Repair in a Selected Group of Patients with Inguinal Hernia Comparable Results to Lichtenstein, TEP and TAPP Techniques?

Has Shouldice Repair in a Selected Group of Patients with Inguinal Hernia Comparable Results to... Background In the new international guidelines only the mesh-based Lichtenstein, TEP and TAPP techniques are recommended. This present analysis of data from the Herniamed Registry compares the outcome for Shouldice versus Lichtenstein, TEP and TAPP. Methods Propensity score matching analyses were performed to obtain homogeneous comparison groups for Shouldice versus Lichtenstein (n = 2115/2608; 81.1%), Shouldice versus TEP (n = 2225/2608; 85.3%) and Shouldice versus TAPP (2400/2608; 92.0%). Results The most important characteristics of the Shouldice patient collective were younger patients with a mean age of 40 years, a large proportion of women of 30%, a mean BMI value of 24 and a proportion of defect sizes up to 3 cm of over 85%. For this selected patient collective, propensity score matched-pair analysis did not identify any difference in the perioperative and one-year follow-up outcome compared with TAPP, fewer intraoperative (0.5 vs. 1.3%; p = 0.009) but somewhat more postoperative complications (2.3 vs. 1.5%; p = 0.050) compared with TEP and advantages with regard to pain at rest (4.6 vs. 6.1%; p = 0.039) and on exertion (10.0 vs. 13.4%; p\ 0.001) compared with the Lichtenstein technique. Conclusion For a selected group of patients the Shouldice technique can be used for primary unilateral inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and TAPP operations. Introduction All the guidelines published to date recommend mesh- based surgical techniques for primary unilateral inguinal hernia repair because of the lower recurrence rate [1–6]. In F. Ko ¨ ckerling and A. Koch have contributed equally to this publication. StatConsult GmbH, Halbersta ¨dter Strasse 40 a, & F. Ko ¨ ckerling 39112 Magdeburg, Germany ferdinand.koeckerling@vivantes.de 3Surgeons, Klosterstrasse 34/35, 13581 Berlin, Germany Department of Surgery and Center for Minimally Invasive Department of General Surgery Wilhelminenspital, Medical Surgery, Academic Teaching Hospital of Charite ´ Medical Faculty, Sigmund Freud University, Montleartstrasse 37, School, Vivantes Hospital, Neue Bergstrasse 6, 13585 Berlin, 1160 Vienna, Austria Germany Hernia Center Cottbus, Gerhard-Hauptmann-Strasse 15, 03044 Cottbus, Germany 123 2002 World J Surg (2018) 42:2001–2010 the guidelines the open Lichtenstein, the total extraperi- practice (Herniamed Study Group) in Germany, Austria toneal patch plasty (TEP) and the transabdominal preperi- and Switzerland (status: March 7, 2016) have entered data toneal patch plasty (TAPP) techniques are recommended as prospectively on their patients who had undergone routine best evidence-based options for repair of a primary uni- hernia surgery. In Germany, surgeons in private practice lateral inguinal hernia provided the surgeon is sufficiently are not employed by a hospital. Rather, they operate on experienced in the specific procedure [6]. The Shouldice patients in outpatient/ambulatory surgical centers or hos- hernia repair technique [7, 8] is the best non-mesh repair pitals for a fee. All patients signed an informed consent method [1, 2]. Other authors propose that mesh repairs agreeing to participate. As part of the information provided should be abandoned and the Shouldice repair adopted to patients regarding participation in the Herniamed Reg- since mesh repair is reported to be associated with an istry and signing the informed consent declaration, all inguinodynia incidence of up to 21% [9]. patients are informed that the treating hospital or medical To date, 380,000 operations have been performed at the practice would like to be informed about any problem Shouldice Hospital in Toronto [10]. On average each sur- occurring after the operation and that the patients have the geon at the Shouldice Hospital operates on 700 patients per opportunity to attend clinical examination. All postopera- year. Using population-based, administrative health data a tive complications occurring up to 30 days after surgery study of Ontario residents who had primary elective inguinal were recorded. At one-year follow-up, postoperative hernia repair at an Ontario hospital between 1993 and 2007 complications are once again reviewed when the general found that inguinal hernia repair at the Shouldice Hospital practitioner and patient complete a questionnaire. At the was associated with a significantly lower risk of subsequent one-year follow-up, the general practitioner and patient are surgery for recurrence than repair at a general hospital [11]. asked about any recurrences, pain at rest, pain on exertion Likewise, the new international guidelines of the Her- and chronic pain requiring treatment. If a recurrence or niaSurge Group [6] recommend a mesh-based repair tech- chronic pain is reported by the general practitioner or nique for patients with symptomatic inguinal hernias. patient, the patient can be requested to present themselves Whether a non-mesh technique is an alternative for mesh- for clinical examination. One publication has provided based techniques in individual cases (e.g., young males with impressive evidence of the role of patient-reported out- lateral hernia L1 and L2) is unknown and requires further come for recurrence and chronic pain [15]. study. Following these recommendations, the best non-mesh The main inclusion criteria were a minimum age of technique Shouldice should only be used in patients refusing 16 years, primary unilateral inguinal hernia, Shouldice, a mesh repair and/or after a shared decision making and in Lichtenstein, TEP or TAPP technique and availability of settings with non-availability of meshes [6]. data at one-year follow-up (Fig. 1). In total, 60,514 patients This present analysis now compares the perioperative were selected between September 1, 2009, and February 1, and one-year follow-up outcome of cases of primary uni- 2015. Of these patients, 2608 had been operated on with lateral inguinal hernia repair documented in the Herniamed the Shouldice, 22,111 with the Lichtenstein, 14,559 with Registry [12, 13] which had been operated on with the TEP and 21,236 with TAPP technique. Pairwise propensity Shouldice versus the Lichtenstein, TEP and TAPP tech- score matching analyses were performed for these 60,514 niques, respectively. As a robust approach for comparative patients to obtain homogeneous comparison groups, each. effectiveness research in observational studies [14] we used For the purpose of the present analyses the mutually propensity score matching to yield comparable groups for independent matching groups Shouldice versus Lichten- analyses. Previous findings from simulated data of obser- stein, Shouldice versus TEP and Shouldice versus TAPP vational studies showed that propensity score analysis were thus formed. could produce estimates that were less biased, more robust and more precise than with multivariable analysis [14]. A Statistical analysis propensity score analysis aims to mimic randomization and thus deals with confounding bias [14]. Using the Herni- All analyses were performed with the software SAS 9.4 amed Registry enables us to take many important potential (SAS Institute Inc., Cary, NC, USA) and intentionally confounding variables into account. calculated to a full significance level of 5%, i.e., they were not corrected with respect to multiple tests, and each p value B0.05 represents a significant result. The periop- Methods erative and one-year follow-up outcome (intra- and post- operative complications, complication-related The Herniamed quality assurance study is a multicenter, reoperations, pain at rest and on exertion, pain requiring Internet-based hernia registry [12, 13] into which 524 treatment and recurrences at one-year follow-up) was participating hospitals and surgeons engaged in private compared for Shouldice versus Lichtenstein, TEP and 123 World J Surg (2018) 42:2001–2010 2003 Fig. 1 Flowchart of patient inclusion TAPP techniques using, first of all, propensity score the 2 9 2 frequency table, the corresponding p values and matching, each. Matched samples were then analyzed via the odds ratio estimates with 95% confidence interval for McNemar’s test. As results the non-diagonal elements of matched samples are given. Propensity score (1:1) 123 2004 World J Surg (2018) 42:2001–2010 matching without replacement was performed using greedy revealed significant differences prior to matching. For algorithm and a caliper of 0.5 standard deviations. The example, compared with their Lichtenstein counterparts, variables used for matching were: age (years), gender patients in the Shouldice group had a significantly lower (male/female), BMI (kg/m ), American Society of Anes- age (41.2 ± 19.7 years vs. 64.6 ± 15.1 years; p\ 0.001) thesiologists ASA Score (I–IV), preoperative pain (yes/no/ and BMI (24.2 ± 3.5 vs. 25.8 ± 3.6; p \ 0.001). Fur- unknown), defect size (European Hernia Society [EHS] thermore, in the Shouldice group the proportion of women classification Grade I \ 1.5 cm, Grade II = 1.5–3 cm, was significantly larger (32.9 vs. 10.1%; p \ 0.001), the Grade III [ 3 cm) [16], defect localization (EHS classifi- hernia defects significantly smaller (p \ 0.001; e.g., EHS cation medial, lateral, femoral, scrotal) [16], anticoagulant I B 1.5 cm 43 vs. 12.8%), the proportion of lateral and therapy with coumarin derivatives (yes/no) and antiplatelet femoral inguinal hernias significantly larger, the proportion therapy with platelet aggregation inhibitors (yes/no). The of scrotal inguinal hernias significantly smaller, the pro- balance of the matched sample was checked using stan- portion of patients with preoperative pain significantly dardized differences (also given for the pre-matched sam- higher, the proportion of patients with continuing treatment ple) that should not exceed 10% (\0.1) after matching. For with coumarin derivatives and with platelet aggregation pairwise comparison of matching parameters between inhibitors significantly lower and the proportion of patients operation methods (for presenting the differences between with higher ASA score significantly lower. the original—pre-matched—samples) Chi-square tests and Propensity score matching was applied to match the t tests (Satterthwaite) were performed for categorical and 2608 patients who had undergone a Shouldice operation continuous variables, respectively. with the 22,111 patients operated on with the Lichtenstein As sensitivity analyses, we estimated one multivariable technique. Matching with the Lichtenstein population was logistic regression model per outcome variable based on all successfully applied for 2115 (81.1%) of the Shouldice data available (n = 60,514) including the variables which patients (Fig. 2). had been chosen for matching. Figure 3 illustrates the standardized differences between the matching variables both before (original sample) and after (matched sample) matching. After matching, the Results Shouldice and Lichtenstein collectives had a comparable age (44.8 ± 19.8 years vs. 45.7 ± 18.1 years), BMI Shouldice versus Lichtenstein (24.7 ± 3.4 vs. 24.7 ± 3.3), proportion of women (26 vs. 26.3%) and defect size (EHS I B 1.5 cm 49.3 vs. 49.2%). Analysis of the variables used for matching when com- Figure 4 gives a summary of the results of matched-pair paring the Shouldice versus Lichtenstein operations analyses for the two surgical techniques, Shouldice and Fig. 2 Flowchart of patient matching 123 World J Surg (2018) 42:2001–2010 2005 Fig. 3 Standardized differences between the matching variables both before (original sample) and after matching (matched sample). *Standardized differences for age (original sample) are 1.333, 0.875 and 0.855 for Shouldice versus Lichtenstein, Shouldice versus TAPP and Shouldice versus TAP, respectively Lichtenstein, for the various outcome parameters. Signifi- with preoperative pain significantly larger, the proportion cant differences were found only for pain at rest and on of patients with continuing therapy with coumarin exertion. A systematic deviation with regard to pain on derivatives and with platelet aggregation inhibitors sig- exertion in favor of the Shouldice operation (10.0 vs. nificantly lower and the proportionofhigherASA scores 13.4%; p = 0.001) was identified at one-year follow-up. significantly lower. That also applied for pain at rest at follow-up (4.6 vs. 6.1%; Propensity score matching was applied to match the p = 0.039). No systematic deviation was detected for any 2608 patients who had undergone a Shouldice operation of the other outcome variables between the Shouldice and with the 14,559 patients operated on with a TEP technique. Lichtenstein techniques. Matching with the TEP population was successfully applied for 2225 (85.3%) of Shouldice patients (Fig. 2). Shouldice versus TEP Figure 3 shows the standardized differences between the matching variables both before (original sample) and after Likewise, analysis of the variables used for matching (matched sample) matching. After matching, the Shouldice when comparing Shouldice versus TEP revealed signifi- and TEP groups had a comparable age (43.7 ± 20.0 vs. cant differences. Here, too, the patients in the Shouldice 44.9 ± 16.9 years), BMI (24.5 ± 3.4 vs. 24.4 ± 3.4), group had a significantly lower age (41.2 ± 19.7 vs. proportion of women (27.3 vs. 30.8%) and defect size 56.4 ± 15.6 years; p \ 0.001) and significantly lower (EHS I B 1.5 cm 48.6 vs. 49.5%). BMI (24.2 ± 3.5 vs. 25.7 ± 3.5; p \ 0.001). Further- Figure 5 gives a summary of the results of matched-pair more, comparison of Shouldice versus TEP showed that in analyses for the two surgical techniques, Shouldice and the Shouldice patient group the proportion of women was TEP, for the various outcome parameters. A systematic significantly higher (32.9 vs. 11.8%; p \ 0.001), the deviation was noted between the two surgical techniques hernia defects significantly smaller (p \ 0.001; e.g., EHS for the intraoperative and postoperative complications. For I B 1.5 cm 43.0 vs. 19.0%), the proportion of medial EHS the intraoperative complications, a significant deviation classifications significantly larger, but that of lateral and was identified in favor of the Shouldice technique (0.5 vs. 1.3%; p = 0.009). Conversely, for the postoperative femoral significantly smaller, the proportion of patients 123 2006 World J Surg (2018) 42:2001–2010 Fig. 4 Results of matched-pair analyses of Shouldice versus Lichtenstein technique of the various outcome parameters Fig. 5 Results of matched-pair analyses of Shouldice versus TEP technique of the various outcome parameters complications a slight deviation was detected in favor of Shouldice versus TAPP TEP (1.5 vs. 2.3%; p = 0.050). No systematic discrepancy was detected between the two operative techniques for any Analysis of the variables used for matching when com- of the other outcome variables. paring Shouldice versus TAPP also revealed significant 123 World J Surg (2018) 42:2001–2010 2007 differences. Significant differences were found, too, on Figure 6 gives a summary of the results of matched-pair comparing age (41.2 ± 19.7 vs. 56.7 ± 15.5 years; analyses for the two surgical techniques, Shouldice and p \ 0.001) and BMI (24.2 ± 3.5 vs. 25.8 ± 3.6; TAPP, for the various outcome parameters. No systematic p \ 0.001), with lower values identified for the Shouldice deviation was identified between Shouldice and TAPP for group. Furthermore, the Shouldice group compared with any of the outcome variables. the TAPP group had a significantly larger proportion of women (32.9 vs. 12.5%; p \ 0.001), significantly smaller Sensitivity analyses hernia defects (p\ 0.001; e.g., EHS I B 1.5 cm 43.0 vs. 17.2%), a significantly larger proportion of medial and a Results are comprised in Fig. 7. significantly smaller proportion of femoral and scrotal Pairwise estimates (OR estimate and its corresponding hernias by EHS classification, a significantly smaller pro- 95% confidence interval) for operation methods (Shouldice portion of patients with no preoperative pain, a signifi- vs. {/Lichtenstein/TEP/TAPP}) are given. Model fit is a cantly smaller proportion of patients with continuing significant except for complication-related reoperations. therapy with coumarin derivatives and with platelet Sensitivity analyses verified our results; OR estimates aggregation inhibitors and a significantly smaller propor- are very close. But here—probably due to larger samples tion of patients with higher ASA score. and a higher power—more significant effects in favor of Propensity score matching was applied to match the the Shouldice method are found. This corresponds to the 2608 patients who had undergone a Shouldice operation literature, and there can be no assurance that those signif- with the 21,236 patients with a TAPP operation. Matching icances are due to overestimation [17, 18]. with the TAPP population was successfully applied for 2400 (92.0%) of the Shouldice patients (Fig. 2). Figure 3 shows the standardized differences between the Discussion matching variables both before (original sample) and after (matched sample) matching. After matching, the Shouldice The aim of the present propensity score analysis of data and TAPP collectives had a comparable age (42.6 ± 19.8 from the Herniamed Registry was to compare the surgical vs. 43.4 ± 16.6 years), BMI (24.4 ± 3.4 vs. 24.4 ± 3.7), techniques of Shouldice versus Lichtenstein, Shouldice proportion of women (28.8 vs. 31.8%) and defect size versus TEP and Shouldice versus TAPP with regard to (EHS I B 1.5 cm 46.6 vs. 45.1%). intra- and postoperative complications, complication-re- lated reoperations as well as recurrence and pain rates at Fig. 6 Results of matched-pair analyses of Shouldice versus TAPP technique of the various outcome parameters 123 2008 World J Surg (2018) 42:2001–2010 Fig. 7 Results of multivariable models (pairwise OR estimates (95% CI)) one-year follow-up. To enhance comparability of these with a mean age of 40 years, larger proportion of women of operative techniques, homogeneous comparison groups around 30%, mean BMI value of 24 and a proportion of were first created for the different variables using propen- EHS I (\1.5 cm) and EHS II (1.5–3 cm) defect sizes of sity score matching. The variables used for matching were more than 85%. Besides, risk factors such as high ASA age, BMI, gender, ASA score, size of the hernia defect, score and continuing treatment with coumarin derivatives EHS classification, preoperative pain and continuing and with platelet aggregation inhibitors were significantly treatment with coumarin derivatives or platelet aggregation less common in the Shouldice group. As such, the patients inhibitors. operated on with the Shouldice technique, as documented Comparison of the Shouldice versus Lichtenstein oper- by the Herniamed Registry, tended to be younger, slimmer, ation revealed a relevant systematic deviance in favor of with smaller defects and no risk factors. The Herniamed the Shouldice technique with significantly less pain at rest data now demonstrate that this selected patient group can and on exertion at one-year follow-up. be operated on with a good outcome with the Shouldice Likewise, on comparing the Shouldice versus TEP a technique and with no evidence of any major disadvantages relevant systematic difference was detected in the intra- coming to light up to the end of first postoperative year operative complications in favor of the Shouldice opera- compared with TAPP. The Shouldice technique was even tion. However, postoperative complications were more found to have advantages over the Lichtenstein operation common on using the Shouldice technique. thanks to lower rates of pain at rest and on exertion at one- On comparing the Shouldice with the TAPP technique, year follow-up. Compared with TEP, the intraoperative no systematic difference was noted for any of the outcome complication rate was significantly lower, but the postop- parameters. erative complication rate was somewhat higher. Similarly, In a multivariable logistic regression model as sensi- an Austrian prospective randomized control trial did not tivity analyses even more significant effects in favor of the find any significant difference between the Shouldice, Shouldice technique are found. But this needs to be care- Bassini, Lichtenstein, TEP and TAPP surgical techniques fully interpreted, because it can be an effect of larger with regard to the recurrence rate and complications up to samples, a higher power or even overestimation [17, 18]. three years following surgery [19]. The results presented here are based on the described A survey of patients from the Danish and Swedish patient collective which was formed as per the typical Hernia Registry which compared 630 Shouldice and 1250 characteristics of the matching variables. The Shouldice Lichtenstein patients with indirect inguinal hernia in young patient collective was characterized by younger patients males identified a significantly lower pain rate for the 123 World J Surg (2018) 42:2001–2010 2009 Shouldice patients and no difference in the rate of new are only partially in concordance with the existing litera- onset of inguinal protrusions [20]. Likewise, a Spanish ture. Additionally, the follow-up is with one year relatively prospective randomized trial identified comparable out- short in view of the time interval needed to find the real comes for the Shouldice and Lichtenstein techniques [21]. recurrence rate [29]. A prospective randomized trial that compared Shouldice In summary, the data presented here from the Herni- versus TEP for primary unilateral inguinal hernia in men amed Registry demonstrate that under routine conditions did not find any significant differences, apart from a longer and on selecting patients on the basis of the influence operative time in the TEP group, between the two methods variables age, weight, gender, defect size, defect localiza- with regard to perioperative complications, hospital stay, tion, preoperative pain and certain risk factors, outcomes recurrences or pain in the groin [22]. comparable with those of the Lichtenstein, TEP and TAPP The largest prospective randomized trial with 1042 techniques can be achieved with the Shouldice operation patients, carried out in Sweden, which compared the for primary unilateral inguinal hernia repair. A ‘tailored Shouldice versus TAPP techniques, did not find any dif- approach’ can be used and should take into account the ferences in the complication rates [23]. Nor was any sig- impact exerted by the variables of interest on the outcome. nificant difference identified in the recurrence rates after Hence, based on the results presented here, younger, non- 5 years [24]. There was also no difference between late overweight patients with defect sizes up to 3 cm and no discomfort at a 5-year follow-up after laparoscopic TAPP other risk factors can be operated on with the Shouldice and Shouldice repair [25]. technique. Additional large prospective randomized trials Therefore, while certain prospective randomized studies are urgently needed for comparison of the Shouldice corroborate the comparative findings identified in this technique with the Lichtenstein, TEP and TAPP mesh- analysis of registry data for the Shouldice, Lichtenstein, based operations recommended in the guidelines. Such TEP and TAPP surgical techniques for repair of primary studies must definitely take into account the variables that unilateral inguinal hernias, some of the meta-analyses impact the outcome (age, BMI, gender, EHS defect size, noted different results [26, 27]. The meta-analysis com- EHS defect localization, ASA score, preoperative pain and prising 27 prospective randomized trials found a signifi- continuing treatment with coumarin derivatives and with cantly higher total morbidity and chronic groin pain rate for platelet aggregation inhibitors). Only in such way can the Shouldice technique compared with the laparo-endo- comparative patient collectives be achieved for effective scopic operation [26]. There were no differences regarding comparison of the methods used for primary unilateral the incidence of hernia recurrence [26]. A Cochrane review inguinal hernia repair. [27] comparing 2566 Shouldice repairs with 1121 open Open Access This article is distributed under the terms of the mesh and 1608 other non-mesh techniques showed a higher Creative Commons Attribution 4.0 International License (http://crea recurrence rate for the Shouldice technique compared with tivecommons.org/licenses/by/4.0/), which permits unrestricted use, other mesh techniques (OR 3.80, 95% CI 1.99–7.26), but a distribution, and reproduction in any medium, provided you give lower recurrence rate compared with other non-mesh appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were techniques (OR 0.62, 95% CI 0.45–0.85). There were no made. significant differences in chronic pain and complications [27]. The corresponding guidelines were then formulated based on these meta-analyses [1–6]. However, the stance References taken in the guidelines in favor of mesh-based techniques in inguinal hernia surgery is the focus of controversial 1. Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Cam- debate in the literature [9], since an inguinodynia rate of panelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schum- over 21% has been reported for mesh procedures. pelick V, Smedberg S, Smietanski M, Weber G, Miserez M Incorrect or missing data limit a registry. In the Herni- (2009) European Hernia Society guidelines on the treatment of amed Hernia Registry the following measurements are inguinal Hernia in adult patients. Hernia 13:343–403. https://doi. org/10.1007/s10029-009-0529-7 used to optimize data entry: signed contract with the 2. Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, responsible surgeon for data correctness and completeness, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, indication of missing data by the software, once again Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smi- review of the perioperative outcome on one-year follow-up tanski M, Weber G, Simons P (2014) Update with level 1 studies of the European Hernia Society guidelines on the treatment of and control of the data entry by experts as part of the inguinal hernia in adult patients. Hernia 18:151–163. https://doi. certification process of hernia centers. The best safeguard is org/10.1007/s10029-014-1236-6 to match the data against another registry, administrative 3. Bittner R, Arregui ME, Bisgaard T, Dudai M, Ferzli GS, data and/or the literature [28]. Due to the high selection of Fitzgibbons RJ, Fortelny RH, Klinge U, Kockerling F, Kuhry E, patients in the Shouldice group the findings presented here Kukleta J, Lomanto D, Misra MC, Montgomery A, Morales- 123 2010 World J Surg (2018) 42:2001–2010 Conde Reinpold W, Rosenberg J, Sauerland S, Schug-Pass C, selective physical examination as a method of follow-up. Eur J Singh K, Timoney MM, Weyhe D, Chowbey P (2011) Guidelines Surg 168:22–28. https://doi.org/10.1080/110241502317307535 for laparoscopic (TAPP) and endoscopic (TEP) treatment of 16. Miserez M, Alexandre JH, Campanelli G, Corcione F, Currurullo inguinal hernia [International Endohernia Society (IEHS)]. Surg D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot Endosc 25:2773–2843. https://doi.org/10.1007/s00464-011-1799- JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB 6 (2007) The European hernia society groin hernia classification: 4. Bittner R, Montgomery MA, Arregui E, Bansal V, Bingener J, simple and easy to remember. Hernia 11:113–116 Bisgaard T, Buhck H, Dudai M, Ferzli GS, Fitzgibbons RJ, 17. Martens EP, Pestman WR, de Boer A, Belitser SV, Klungel OH Fortelny RH, Grimes KL, Klinge U, Kockerling F, Kumar S, (2008) Systematic differences in treatment effect estimates Kukleta J, Lomanto D, Misra MC, Morales-Conde S, Reinpold between propensity score methods and logistic regression. Int J W, Rosenberg J, Singh K, Timoney M, Weyhe D, Chowbey P Epidemiol 37:1142–1147 (2015) Update of guidelines on laparoscopic (TAPP) and endo- 18. Shah BR, Laupais A, Hux JE, Austin PC (2005) Propensity score scopic (TEP) treatment of inguinal hernia (International Endoh- methods gave similar results to traditional regression modeling in ernia Society). Surg Endosc 29:289–321. https://doi.org/10.1007/ observational studies: a systematic review. J Clin Epidemiol s00464-014-3917-8 58:550–559 5. Poelman MM, van den Heuvel B, Deelder JD, Abis GSA, Beu- 19. Pokorny H, Klingler A, Schmid T, Fortelny R, Hollinsky C, deker N, Bittner R, Campanelli G, van Dam D, Dwars BJ, Eker Kawji R, Steiner E, Pernthaler H, Fu ¨ gger R, Scheyer M (2008) HH, Fingerhut A, Khatkov I, Kockerling F, Kukleta JF, Miserez Recurrence and complications after laparoscopic versus open M, Montgomery A, Munoz Brands RM, Morales-Conde S, inguinal hernia repair: results of a prospective randomized mul- Muysoms FE, Soltes M, Tromp W, Yavuz Y, Bonjer HJ (2013) ticenter trial. Hernia 12:385–389. https://doi.org/10.1007/s10029- EAES consensus development conference on endoscopic repair 008-0357-1 of groin hernias. Surg Endosc 27:3505–3519. https://doi.org/10. 20. Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H (2004) Chronic 1007/s00464-013-3001-9 pain after open mesh and sutured repair of indirect inguinal 6. Simons MP, Aufenacker TJ, Berrevoet F, Bingener J, Bisgaard T, hernia in young males. Br J Surg 91:1372–1376 Bittner R, Bonjer HJ, Bury K, Campanelli G, Chen DC, Chowbey 21. Porrero JL, Bonachia O, Lopez-Buenadicha A, Sanjuanbenito A, PK, Conze J, Cuccurullo D, de Beaux AC, Eker HH, Fitzgibbons Sanchez-Cabezudo C (2005) Repair of primary inguinal hernia: RJ, Fortelny RH, Gillion JF, van den Heuvel BJ, Hope WW, Lichtenstein versus Shouldice techniques. Prospective random- Jorgensen LN, Klinge U, Kockerling F, Kukleta JF, Konate I, ized study of pain and hospital costs. Cir Esp 2:75–78 ¨ ¨ Liem AL, Lomanto D, Loos MJA, Lopez-Cano M, Miserez M, 22. Wennstrom J, Berggren P, Akerud L, Jarhult J (2004) Equal Misra MC, Montgomery A, Morales-Conde S, Muysoms FE, results with laparoscopic and Shouldice repairs of primary Niebuhr H, Nordin P, Pawlak M, van Ramshorst GH, Reinpold inguinal hernia in men. Report from a prospective randomized WMJ, Sanders DL, Sani R, Schouten N, Smedberg S, Smietanski study. Scand J Surg 1:34–36 M, Simmermacher RKJ, Tran HM, Tumtavitikul S, van Vee- 23. Berndsen F, Arvidsson D, Enander LK, Leijonmarck CE, Win- nendaal N, Weyhe D, Wijsmuller AR (2018) International gren U, Rudberg C, Smedberg S, Wickbom G, Montgomery A guidelines for groin hernia management. Hernia. https://doi.org/ (2002) Postoperative convalescence after inguinal hernia surgery: 10.1007/s10029-017-1668-x prospective randomized multicenter study of laparoscopic versus 7. Shouldice EB (2003) The Shouldice repair of groin hernias. Surg shouldice inguinal hernia repair in 1042 patients. Hernia 2:56–61 Clin N Am 83:1163–1187. https://doi.org/10.1016/S0039- 24. Arvidsson D, Berndsen FH, Larsson LG, Leijonmarck CE, Rim- 6109(03)00121-X ba ¨ck G, Rudberg C, Smedberg S, Spangen L, Montgomery A 8. Shouldice EB (2010) Surgery illustrated—surgical atlas the (2005) Randomized clinical trial comparing 5-year recurrence rate shouldice natural tissue repair for inguinal hernia. BJU Int after laparoscopic versus Shouldice repair of primary inguinal 105:428–439. https://doi.org/10.1111/j.1464-410X.s009.09155.x hernia. Br J Surg 92:1085–1091. https://doi.org/10.1002/bjs.5137 9. Fischer JE (2013) Hernia repair: why do we continue to perform 25. Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE, mesh repair in the face of the human toll of inguinodynia? Am J Rudberg C, Smedberg S, Montgomery A (2007) Discomfort five Surg 206:619–623. https://doi.org/10.1016/j.amjsurg.2013.03.010 years after laparoscopic and Shouldice inguinal hernia repair: a 10. Shouldice Hospital (2016) www.shouldice.com/the-shouldice- randomized trial with 867 patients. A report from the SMIL study hernia-repair-surgery.html group. Hernia 11:307–313. https://doi.org/10.1007/s10029-007- 11. Malik A, Bell CM, Stukel TA, Urbach DR (2016) Recurrence of 0214-7 inguinal hernias repaired in a large hernia surgical specialty 26. Bittner R, Sauerland S, Schmedt CG (2005) Comparison of hospital and general hospitals in Ontario, Canada. Can J Surg endoscopic techniques vs Shouldice and other open nonmesh 1:19–25. https://doi.org/10.1503/cjs.003915 techniques for inguinal hernia repair: a meta-analysis of ran- 12. Stechemesser B, Jacob DA, Schug-Paß C, Ko ¨ ckerling F (2012) domized controlled trials. Surg Endosc 5:605–615 Herniamed: an internet-based registry for outcome research in 27. Amato B, Moja L, Panico S, Persico G, Rispoli C, Rocco N, hernia surgery. Hernia 16:269–276. https://doi.org/10.1007/ Moschetti I (2012) Shouldice technique versus other open tech- s10029-012-0908-3 niques for inguinal hernia repair. Cochrane Database Syst Rev 13. Kockerling F, Simons T, Hukauf M, Hellinger A, Fortelny R, 18:CD001543. https://doi.org/10.1002/14651858.cd001543.pub4 Reinpold W, Bittner R (2017) The importance of registries in the 28. Hannan EL, Cozzens K, King SB et al (2012) The New York postmarketing surveillance of surgical meshes. Ann Surg. https:// State Cardiac Registries: history, contributions, limitations, and doi.org/10.1097/SLA.0000000000002326 lessons for future efforts to assess and publicly report healthcare 14. Lonjon G, Porcher R, Ergina P, Fouet M (2017) Boutron i outcomes. JACC 59:2309–2316 potential pitfalls of reporting and bias in observational studies 29. Ko ¨ ckerling F, Koch A, Lorenz R, Schug-Pass C, Stechemesser B, with propensity score analysis assessing a surgical procedure. Reinpold W (2015) How long do we need to follow-up our hernia Ann Surg 265:901–909. https://doi.org/10.1097/SLA. patients to find the real recurrence rate? Front Surg 2:24. https:// 0000000000001797 doi.org/10.3389/surg.2015.00024 15. Haapaniemi S, Nilsson E (2002) Recurrence and pain three years after groin hernia repair. Validation of postal questionnaire and http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png World Journal of Surgery Springer Journals

Has Shouldice Repair in a Selected Group of Patients with Inguinal Hernia Comparable Results to Lichtenstein, TEP and TAPP Techniques?

Free
10 pages

Loading next page...
 
/lp/springer_journal/has-shouldice-repair-in-a-selected-group-of-patients-with-inguinal-jiFk0K9HP2
Publisher
Springer Journals
Copyright
Copyright © 2018 by The Author(s)
Subject
Medicine & Public Health; Surgery; Abdominal Surgery; Cardiac Surgery; General Surgery; Thoracic Surgery; Vascular Surgery
ISSN
0364-2313
eISSN
1432-2323
D.O.I.
10.1007/s00268-017-4433-5
Publisher site
See Article on Publisher Site

Abstract

Background In the new international guidelines only the mesh-based Lichtenstein, TEP and TAPP techniques are recommended. This present analysis of data from the Herniamed Registry compares the outcome for Shouldice versus Lichtenstein, TEP and TAPP. Methods Propensity score matching analyses were performed to obtain homogeneous comparison groups for Shouldice versus Lichtenstein (n = 2115/2608; 81.1%), Shouldice versus TEP (n = 2225/2608; 85.3%) and Shouldice versus TAPP (2400/2608; 92.0%). Results The most important characteristics of the Shouldice patient collective were younger patients with a mean age of 40 years, a large proportion of women of 30%, a mean BMI value of 24 and a proportion of defect sizes up to 3 cm of over 85%. For this selected patient collective, propensity score matched-pair analysis did not identify any difference in the perioperative and one-year follow-up outcome compared with TAPP, fewer intraoperative (0.5 vs. 1.3%; p = 0.009) but somewhat more postoperative complications (2.3 vs. 1.5%; p = 0.050) compared with TEP and advantages with regard to pain at rest (4.6 vs. 6.1%; p = 0.039) and on exertion (10.0 vs. 13.4%; p\ 0.001) compared with the Lichtenstein technique. Conclusion For a selected group of patients the Shouldice technique can be used for primary unilateral inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and TAPP operations. Introduction All the guidelines published to date recommend mesh- based surgical techniques for primary unilateral inguinal hernia repair because of the lower recurrence rate [1–6]. In F. Ko ¨ ckerling and A. Koch have contributed equally to this publication. StatConsult GmbH, Halbersta ¨dter Strasse 40 a, & F. Ko ¨ ckerling 39112 Magdeburg, Germany ferdinand.koeckerling@vivantes.de 3Surgeons, Klosterstrasse 34/35, 13581 Berlin, Germany Department of Surgery and Center for Minimally Invasive Department of General Surgery Wilhelminenspital, Medical Surgery, Academic Teaching Hospital of Charite ´ Medical Faculty, Sigmund Freud University, Montleartstrasse 37, School, Vivantes Hospital, Neue Bergstrasse 6, 13585 Berlin, 1160 Vienna, Austria Germany Hernia Center Cottbus, Gerhard-Hauptmann-Strasse 15, 03044 Cottbus, Germany 123 2002 World J Surg (2018) 42:2001–2010 the guidelines the open Lichtenstein, the total extraperi- practice (Herniamed Study Group) in Germany, Austria toneal patch plasty (TEP) and the transabdominal preperi- and Switzerland (status: March 7, 2016) have entered data toneal patch plasty (TAPP) techniques are recommended as prospectively on their patients who had undergone routine best evidence-based options for repair of a primary uni- hernia surgery. In Germany, surgeons in private practice lateral inguinal hernia provided the surgeon is sufficiently are not employed by a hospital. Rather, they operate on experienced in the specific procedure [6]. The Shouldice patients in outpatient/ambulatory surgical centers or hos- hernia repair technique [7, 8] is the best non-mesh repair pitals for a fee. All patients signed an informed consent method [1, 2]. Other authors propose that mesh repairs agreeing to participate. As part of the information provided should be abandoned and the Shouldice repair adopted to patients regarding participation in the Herniamed Reg- since mesh repair is reported to be associated with an istry and signing the informed consent declaration, all inguinodynia incidence of up to 21% [9]. patients are informed that the treating hospital or medical To date, 380,000 operations have been performed at the practice would like to be informed about any problem Shouldice Hospital in Toronto [10]. On average each sur- occurring after the operation and that the patients have the geon at the Shouldice Hospital operates on 700 patients per opportunity to attend clinical examination. All postopera- year. Using population-based, administrative health data a tive complications occurring up to 30 days after surgery study of Ontario residents who had primary elective inguinal were recorded. At one-year follow-up, postoperative hernia repair at an Ontario hospital between 1993 and 2007 complications are once again reviewed when the general found that inguinal hernia repair at the Shouldice Hospital practitioner and patient complete a questionnaire. At the was associated with a significantly lower risk of subsequent one-year follow-up, the general practitioner and patient are surgery for recurrence than repair at a general hospital [11]. asked about any recurrences, pain at rest, pain on exertion Likewise, the new international guidelines of the Her- and chronic pain requiring treatment. If a recurrence or niaSurge Group [6] recommend a mesh-based repair tech- chronic pain is reported by the general practitioner or nique for patients with symptomatic inguinal hernias. patient, the patient can be requested to present themselves Whether a non-mesh technique is an alternative for mesh- for clinical examination. One publication has provided based techniques in individual cases (e.g., young males with impressive evidence of the role of patient-reported out- lateral hernia L1 and L2) is unknown and requires further come for recurrence and chronic pain [15]. study. Following these recommendations, the best non-mesh The main inclusion criteria were a minimum age of technique Shouldice should only be used in patients refusing 16 years, primary unilateral inguinal hernia, Shouldice, a mesh repair and/or after a shared decision making and in Lichtenstein, TEP or TAPP technique and availability of settings with non-availability of meshes [6]. data at one-year follow-up (Fig. 1). In total, 60,514 patients This present analysis now compares the perioperative were selected between September 1, 2009, and February 1, and one-year follow-up outcome of cases of primary uni- 2015. Of these patients, 2608 had been operated on with lateral inguinal hernia repair documented in the Herniamed the Shouldice, 22,111 with the Lichtenstein, 14,559 with Registry [12, 13] which had been operated on with the TEP and 21,236 with TAPP technique. Pairwise propensity Shouldice versus the Lichtenstein, TEP and TAPP tech- score matching analyses were performed for these 60,514 niques, respectively. As a robust approach for comparative patients to obtain homogeneous comparison groups, each. effectiveness research in observational studies [14] we used For the purpose of the present analyses the mutually propensity score matching to yield comparable groups for independent matching groups Shouldice versus Lichten- analyses. Previous findings from simulated data of obser- stein, Shouldice versus TEP and Shouldice versus TAPP vational studies showed that propensity score analysis were thus formed. could produce estimates that were less biased, more robust and more precise than with multivariable analysis [14]. A Statistical analysis propensity score analysis aims to mimic randomization and thus deals with confounding bias [14]. Using the Herni- All analyses were performed with the software SAS 9.4 amed Registry enables us to take many important potential (SAS Institute Inc., Cary, NC, USA) and intentionally confounding variables into account. calculated to a full significance level of 5%, i.e., they were not corrected with respect to multiple tests, and each p value B0.05 represents a significant result. The periop- Methods erative and one-year follow-up outcome (intra- and post- operative complications, complication-related The Herniamed quality assurance study is a multicenter, reoperations, pain at rest and on exertion, pain requiring Internet-based hernia registry [12, 13] into which 524 treatment and recurrences at one-year follow-up) was participating hospitals and surgeons engaged in private compared for Shouldice versus Lichtenstein, TEP and 123 World J Surg (2018) 42:2001–2010 2003 Fig. 1 Flowchart of patient inclusion TAPP techniques using, first of all, propensity score the 2 9 2 frequency table, the corresponding p values and matching, each. Matched samples were then analyzed via the odds ratio estimates with 95% confidence interval for McNemar’s test. As results the non-diagonal elements of matched samples are given. Propensity score (1:1) 123 2004 World J Surg (2018) 42:2001–2010 matching without replacement was performed using greedy revealed significant differences prior to matching. For algorithm and a caliper of 0.5 standard deviations. The example, compared with their Lichtenstein counterparts, variables used for matching were: age (years), gender patients in the Shouldice group had a significantly lower (male/female), BMI (kg/m ), American Society of Anes- age (41.2 ± 19.7 years vs. 64.6 ± 15.1 years; p\ 0.001) thesiologists ASA Score (I–IV), preoperative pain (yes/no/ and BMI (24.2 ± 3.5 vs. 25.8 ± 3.6; p \ 0.001). Fur- unknown), defect size (European Hernia Society [EHS] thermore, in the Shouldice group the proportion of women classification Grade I \ 1.5 cm, Grade II = 1.5–3 cm, was significantly larger (32.9 vs. 10.1%; p \ 0.001), the Grade III [ 3 cm) [16], defect localization (EHS classifi- hernia defects significantly smaller (p \ 0.001; e.g., EHS cation medial, lateral, femoral, scrotal) [16], anticoagulant I B 1.5 cm 43 vs. 12.8%), the proportion of lateral and therapy with coumarin derivatives (yes/no) and antiplatelet femoral inguinal hernias significantly larger, the proportion therapy with platelet aggregation inhibitors (yes/no). The of scrotal inguinal hernias significantly smaller, the pro- balance of the matched sample was checked using stan- portion of patients with preoperative pain significantly dardized differences (also given for the pre-matched sam- higher, the proportion of patients with continuing treatment ple) that should not exceed 10% (\0.1) after matching. For with coumarin derivatives and with platelet aggregation pairwise comparison of matching parameters between inhibitors significantly lower and the proportion of patients operation methods (for presenting the differences between with higher ASA score significantly lower. the original—pre-matched—samples) Chi-square tests and Propensity score matching was applied to match the t tests (Satterthwaite) were performed for categorical and 2608 patients who had undergone a Shouldice operation continuous variables, respectively. with the 22,111 patients operated on with the Lichtenstein As sensitivity analyses, we estimated one multivariable technique. Matching with the Lichtenstein population was logistic regression model per outcome variable based on all successfully applied for 2115 (81.1%) of the Shouldice data available (n = 60,514) including the variables which patients (Fig. 2). had been chosen for matching. Figure 3 illustrates the standardized differences between the matching variables both before (original sample) and after (matched sample) matching. After matching, the Results Shouldice and Lichtenstein collectives had a comparable age (44.8 ± 19.8 years vs. 45.7 ± 18.1 years), BMI Shouldice versus Lichtenstein (24.7 ± 3.4 vs. 24.7 ± 3.3), proportion of women (26 vs. 26.3%) and defect size (EHS I B 1.5 cm 49.3 vs. 49.2%). Analysis of the variables used for matching when com- Figure 4 gives a summary of the results of matched-pair paring the Shouldice versus Lichtenstein operations analyses for the two surgical techniques, Shouldice and Fig. 2 Flowchart of patient matching 123 World J Surg (2018) 42:2001–2010 2005 Fig. 3 Standardized differences between the matching variables both before (original sample) and after matching (matched sample). *Standardized differences for age (original sample) are 1.333, 0.875 and 0.855 for Shouldice versus Lichtenstein, Shouldice versus TAPP and Shouldice versus TAP, respectively Lichtenstein, for the various outcome parameters. Signifi- with preoperative pain significantly larger, the proportion cant differences were found only for pain at rest and on of patients with continuing therapy with coumarin exertion. A systematic deviation with regard to pain on derivatives and with platelet aggregation inhibitors sig- exertion in favor of the Shouldice operation (10.0 vs. nificantly lower and the proportionofhigherASA scores 13.4%; p = 0.001) was identified at one-year follow-up. significantly lower. That also applied for pain at rest at follow-up (4.6 vs. 6.1%; Propensity score matching was applied to match the p = 0.039). No systematic deviation was detected for any 2608 patients who had undergone a Shouldice operation of the other outcome variables between the Shouldice and with the 14,559 patients operated on with a TEP technique. Lichtenstein techniques. Matching with the TEP population was successfully applied for 2225 (85.3%) of Shouldice patients (Fig. 2). Shouldice versus TEP Figure 3 shows the standardized differences between the matching variables both before (original sample) and after Likewise, analysis of the variables used for matching (matched sample) matching. After matching, the Shouldice when comparing Shouldice versus TEP revealed signifi- and TEP groups had a comparable age (43.7 ± 20.0 vs. cant differences. Here, too, the patients in the Shouldice 44.9 ± 16.9 years), BMI (24.5 ± 3.4 vs. 24.4 ± 3.4), group had a significantly lower age (41.2 ± 19.7 vs. proportion of women (27.3 vs. 30.8%) and defect size 56.4 ± 15.6 years; p \ 0.001) and significantly lower (EHS I B 1.5 cm 48.6 vs. 49.5%). BMI (24.2 ± 3.5 vs. 25.7 ± 3.5; p \ 0.001). Further- Figure 5 gives a summary of the results of matched-pair more, comparison of Shouldice versus TEP showed that in analyses for the two surgical techniques, Shouldice and the Shouldice patient group the proportion of women was TEP, for the various outcome parameters. A systematic significantly higher (32.9 vs. 11.8%; p \ 0.001), the deviation was noted between the two surgical techniques hernia defects significantly smaller (p \ 0.001; e.g., EHS for the intraoperative and postoperative complications. For I B 1.5 cm 43.0 vs. 19.0%), the proportion of medial EHS the intraoperative complications, a significant deviation classifications significantly larger, but that of lateral and was identified in favor of the Shouldice technique (0.5 vs. 1.3%; p = 0.009). Conversely, for the postoperative femoral significantly smaller, the proportion of patients 123 2006 World J Surg (2018) 42:2001–2010 Fig. 4 Results of matched-pair analyses of Shouldice versus Lichtenstein technique of the various outcome parameters Fig. 5 Results of matched-pair analyses of Shouldice versus TEP technique of the various outcome parameters complications a slight deviation was detected in favor of Shouldice versus TAPP TEP (1.5 vs. 2.3%; p = 0.050). No systematic discrepancy was detected between the two operative techniques for any Analysis of the variables used for matching when com- of the other outcome variables. paring Shouldice versus TAPP also revealed significant 123 World J Surg (2018) 42:2001–2010 2007 differences. Significant differences were found, too, on Figure 6 gives a summary of the results of matched-pair comparing age (41.2 ± 19.7 vs. 56.7 ± 15.5 years; analyses for the two surgical techniques, Shouldice and p \ 0.001) and BMI (24.2 ± 3.5 vs. 25.8 ± 3.6; TAPP, for the various outcome parameters. No systematic p \ 0.001), with lower values identified for the Shouldice deviation was identified between Shouldice and TAPP for group. Furthermore, the Shouldice group compared with any of the outcome variables. the TAPP group had a significantly larger proportion of women (32.9 vs. 12.5%; p \ 0.001), significantly smaller Sensitivity analyses hernia defects (p\ 0.001; e.g., EHS I B 1.5 cm 43.0 vs. 17.2%), a significantly larger proportion of medial and a Results are comprised in Fig. 7. significantly smaller proportion of femoral and scrotal Pairwise estimates (OR estimate and its corresponding hernias by EHS classification, a significantly smaller pro- 95% confidence interval) for operation methods (Shouldice portion of patients with no preoperative pain, a signifi- vs. {/Lichtenstein/TEP/TAPP}) are given. Model fit is a cantly smaller proportion of patients with continuing significant except for complication-related reoperations. therapy with coumarin derivatives and with platelet Sensitivity analyses verified our results; OR estimates aggregation inhibitors and a significantly smaller propor- are very close. But here—probably due to larger samples tion of patients with higher ASA score. and a higher power—more significant effects in favor of Propensity score matching was applied to match the the Shouldice method are found. This corresponds to the 2608 patients who had undergone a Shouldice operation literature, and there can be no assurance that those signif- with the 21,236 patients with a TAPP operation. Matching icances are due to overestimation [17, 18]. with the TAPP population was successfully applied for 2400 (92.0%) of the Shouldice patients (Fig. 2). Figure 3 shows the standardized differences between the Discussion matching variables both before (original sample) and after (matched sample) matching. After matching, the Shouldice The aim of the present propensity score analysis of data and TAPP collectives had a comparable age (42.6 ± 19.8 from the Herniamed Registry was to compare the surgical vs. 43.4 ± 16.6 years), BMI (24.4 ± 3.4 vs. 24.4 ± 3.7), techniques of Shouldice versus Lichtenstein, Shouldice proportion of women (28.8 vs. 31.8%) and defect size versus TEP and Shouldice versus TAPP with regard to (EHS I B 1.5 cm 46.6 vs. 45.1%). intra- and postoperative complications, complication-re- lated reoperations as well as recurrence and pain rates at Fig. 6 Results of matched-pair analyses of Shouldice versus TAPP technique of the various outcome parameters 123 2008 World J Surg (2018) 42:2001–2010 Fig. 7 Results of multivariable models (pairwise OR estimates (95% CI)) one-year follow-up. To enhance comparability of these with a mean age of 40 years, larger proportion of women of operative techniques, homogeneous comparison groups around 30%, mean BMI value of 24 and a proportion of were first created for the different variables using propen- EHS I (\1.5 cm) and EHS II (1.5–3 cm) defect sizes of sity score matching. The variables used for matching were more than 85%. Besides, risk factors such as high ASA age, BMI, gender, ASA score, size of the hernia defect, score and continuing treatment with coumarin derivatives EHS classification, preoperative pain and continuing and with platelet aggregation inhibitors were significantly treatment with coumarin derivatives or platelet aggregation less common in the Shouldice group. As such, the patients inhibitors. operated on with the Shouldice technique, as documented Comparison of the Shouldice versus Lichtenstein oper- by the Herniamed Registry, tended to be younger, slimmer, ation revealed a relevant systematic deviance in favor of with smaller defects and no risk factors. The Herniamed the Shouldice technique with significantly less pain at rest data now demonstrate that this selected patient group can and on exertion at one-year follow-up. be operated on with a good outcome with the Shouldice Likewise, on comparing the Shouldice versus TEP a technique and with no evidence of any major disadvantages relevant systematic difference was detected in the intra- coming to light up to the end of first postoperative year operative complications in favor of the Shouldice opera- compared with TAPP. The Shouldice technique was even tion. However, postoperative complications were more found to have advantages over the Lichtenstein operation common on using the Shouldice technique. thanks to lower rates of pain at rest and on exertion at one- On comparing the Shouldice with the TAPP technique, year follow-up. Compared with TEP, the intraoperative no systematic difference was noted for any of the outcome complication rate was significantly lower, but the postop- parameters. erative complication rate was somewhat higher. Similarly, In a multivariable logistic regression model as sensi- an Austrian prospective randomized control trial did not tivity analyses even more significant effects in favor of the find any significant difference between the Shouldice, Shouldice technique are found. But this needs to be care- Bassini, Lichtenstein, TEP and TAPP surgical techniques fully interpreted, because it can be an effect of larger with regard to the recurrence rate and complications up to samples, a higher power or even overestimation [17, 18]. three years following surgery [19]. The results presented here are based on the described A survey of patients from the Danish and Swedish patient collective which was formed as per the typical Hernia Registry which compared 630 Shouldice and 1250 characteristics of the matching variables. The Shouldice Lichtenstein patients with indirect inguinal hernia in young patient collective was characterized by younger patients males identified a significantly lower pain rate for the 123 World J Surg (2018) 42:2001–2010 2009 Shouldice patients and no difference in the rate of new are only partially in concordance with the existing litera- onset of inguinal protrusions [20]. Likewise, a Spanish ture. Additionally, the follow-up is with one year relatively prospective randomized trial identified comparable out- short in view of the time interval needed to find the real comes for the Shouldice and Lichtenstein techniques [21]. recurrence rate [29]. A prospective randomized trial that compared Shouldice In summary, the data presented here from the Herni- versus TEP for primary unilateral inguinal hernia in men amed Registry demonstrate that under routine conditions did not find any significant differences, apart from a longer and on selecting patients on the basis of the influence operative time in the TEP group, between the two methods variables age, weight, gender, defect size, defect localiza- with regard to perioperative complications, hospital stay, tion, preoperative pain and certain risk factors, outcomes recurrences or pain in the groin [22]. comparable with those of the Lichtenstein, TEP and TAPP The largest prospective randomized trial with 1042 techniques can be achieved with the Shouldice operation patients, carried out in Sweden, which compared the for primary unilateral inguinal hernia repair. A ‘tailored Shouldice versus TAPP techniques, did not find any dif- approach’ can be used and should take into account the ferences in the complication rates [23]. Nor was any sig- impact exerted by the variables of interest on the outcome. nificant difference identified in the recurrence rates after Hence, based on the results presented here, younger, non- 5 years [24]. There was also no difference between late overweight patients with defect sizes up to 3 cm and no discomfort at a 5-year follow-up after laparoscopic TAPP other risk factors can be operated on with the Shouldice and Shouldice repair [25]. technique. Additional large prospective randomized trials Therefore, while certain prospective randomized studies are urgently needed for comparison of the Shouldice corroborate the comparative findings identified in this technique with the Lichtenstein, TEP and TAPP mesh- analysis of registry data for the Shouldice, Lichtenstein, based operations recommended in the guidelines. Such TEP and TAPP surgical techniques for repair of primary studies must definitely take into account the variables that unilateral inguinal hernias, some of the meta-analyses impact the outcome (age, BMI, gender, EHS defect size, noted different results [26, 27]. The meta-analysis com- EHS defect localization, ASA score, preoperative pain and prising 27 prospective randomized trials found a signifi- continuing treatment with coumarin derivatives and with cantly higher total morbidity and chronic groin pain rate for platelet aggregation inhibitors). Only in such way can the Shouldice technique compared with the laparo-endo- comparative patient collectives be achieved for effective scopic operation [26]. There were no differences regarding comparison of the methods used for primary unilateral the incidence of hernia recurrence [26]. A Cochrane review inguinal hernia repair. [27] comparing 2566 Shouldice repairs with 1121 open Open Access This article is distributed under the terms of the mesh and 1608 other non-mesh techniques showed a higher Creative Commons Attribution 4.0 International License (http://crea recurrence rate for the Shouldice technique compared with tivecommons.org/licenses/by/4.0/), which permits unrestricted use, other mesh techniques (OR 3.80, 95% CI 1.99–7.26), but a distribution, and reproduction in any medium, provided you give lower recurrence rate compared with other non-mesh appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were techniques (OR 0.62, 95% CI 0.45–0.85). There were no made. significant differences in chronic pain and complications [27]. The corresponding guidelines were then formulated based on these meta-analyses [1–6]. However, the stance References taken in the guidelines in favor of mesh-based techniques in inguinal hernia surgery is the focus of controversial 1. Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Cam- debate in the literature [9], since an inguinodynia rate of panelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schum- over 21% has been reported for mesh procedures. pelick V, Smedberg S, Smietanski M, Weber G, Miserez M Incorrect or missing data limit a registry. In the Herni- (2009) European Hernia Society guidelines on the treatment of amed Hernia Registry the following measurements are inguinal Hernia in adult patients. Hernia 13:343–403. https://doi. org/10.1007/s10029-009-0529-7 used to optimize data entry: signed contract with the 2. Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, responsible surgeon for data correctness and completeness, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, indication of missing data by the software, once again Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smi- review of the perioperative outcome on one-year follow-up tanski M, Weber G, Simons P (2014) Update with level 1 studies of the European Hernia Society guidelines on the treatment of and control of the data entry by experts as part of the inguinal hernia in adult patients. Hernia 18:151–163. https://doi. certification process of hernia centers. The best safeguard is org/10.1007/s10029-014-1236-6 to match the data against another registry, administrative 3. Bittner R, Arregui ME, Bisgaard T, Dudai M, Ferzli GS, data and/or the literature [28]. Due to the high selection of Fitzgibbons RJ, Fortelny RH, Klinge U, Kockerling F, Kuhry E, patients in the Shouldice group the findings presented here Kukleta J, Lomanto D, Misra MC, Montgomery A, Morales- 123 2010 World J Surg (2018) 42:2001–2010 Conde Reinpold W, Rosenberg J, Sauerland S, Schug-Pass C, selective physical examination as a method of follow-up. Eur J Singh K, Timoney MM, Weyhe D, Chowbey P (2011) Guidelines Surg 168:22–28. https://doi.org/10.1080/110241502317307535 for laparoscopic (TAPP) and endoscopic (TEP) treatment of 16. Miserez M, Alexandre JH, Campanelli G, Corcione F, Currurullo inguinal hernia [International Endohernia Society (IEHS)]. Surg D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot Endosc 25:2773–2843. https://doi.org/10.1007/s00464-011-1799- JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB 6 (2007) The European hernia society groin hernia classification: 4. Bittner R, Montgomery MA, Arregui E, Bansal V, Bingener J, simple and easy to remember. Hernia 11:113–116 Bisgaard T, Buhck H, Dudai M, Ferzli GS, Fitzgibbons RJ, 17. Martens EP, Pestman WR, de Boer A, Belitser SV, Klungel OH Fortelny RH, Grimes KL, Klinge U, Kockerling F, Kumar S, (2008) Systematic differences in treatment effect estimates Kukleta J, Lomanto D, Misra MC, Morales-Conde S, Reinpold between propensity score methods and logistic regression. Int J W, Rosenberg J, Singh K, Timoney M, Weyhe D, Chowbey P Epidemiol 37:1142–1147 (2015) Update of guidelines on laparoscopic (TAPP) and endo- 18. Shah BR, Laupais A, Hux JE, Austin PC (2005) Propensity score scopic (TEP) treatment of inguinal hernia (International Endoh- methods gave similar results to traditional regression modeling in ernia Society). Surg Endosc 29:289–321. https://doi.org/10.1007/ observational studies: a systematic review. J Clin Epidemiol s00464-014-3917-8 58:550–559 5. Poelman MM, van den Heuvel B, Deelder JD, Abis GSA, Beu- 19. Pokorny H, Klingler A, Schmid T, Fortelny R, Hollinsky C, deker N, Bittner R, Campanelli G, van Dam D, Dwars BJ, Eker Kawji R, Steiner E, Pernthaler H, Fu ¨ gger R, Scheyer M (2008) HH, Fingerhut A, Khatkov I, Kockerling F, Kukleta JF, Miserez Recurrence and complications after laparoscopic versus open M, Montgomery A, Munoz Brands RM, Morales-Conde S, inguinal hernia repair: results of a prospective randomized mul- Muysoms FE, Soltes M, Tromp W, Yavuz Y, Bonjer HJ (2013) ticenter trial. Hernia 12:385–389. https://doi.org/10.1007/s10029- EAES consensus development conference on endoscopic repair 008-0357-1 of groin hernias. Surg Endosc 27:3505–3519. https://doi.org/10. 20. Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H (2004) Chronic 1007/s00464-013-3001-9 pain after open mesh and sutured repair of indirect inguinal 6. Simons MP, Aufenacker TJ, Berrevoet F, Bingener J, Bisgaard T, hernia in young males. Br J Surg 91:1372–1376 Bittner R, Bonjer HJ, Bury K, Campanelli G, Chen DC, Chowbey 21. Porrero JL, Bonachia O, Lopez-Buenadicha A, Sanjuanbenito A, PK, Conze J, Cuccurullo D, de Beaux AC, Eker HH, Fitzgibbons Sanchez-Cabezudo C (2005) Repair of primary inguinal hernia: RJ, Fortelny RH, Gillion JF, van den Heuvel BJ, Hope WW, Lichtenstein versus Shouldice techniques. Prospective random- Jorgensen LN, Klinge U, Kockerling F, Kukleta JF, Konate I, ized study of pain and hospital costs. Cir Esp 2:75–78 ¨ ¨ Liem AL, Lomanto D, Loos MJA, Lopez-Cano M, Miserez M, 22. Wennstrom J, Berggren P, Akerud L, Jarhult J (2004) Equal Misra MC, Montgomery A, Morales-Conde S, Muysoms FE, results with laparoscopic and Shouldice repairs of primary Niebuhr H, Nordin P, Pawlak M, van Ramshorst GH, Reinpold inguinal hernia in men. Report from a prospective randomized WMJ, Sanders DL, Sani R, Schouten N, Smedberg S, Smietanski study. Scand J Surg 1:34–36 M, Simmermacher RKJ, Tran HM, Tumtavitikul S, van Vee- 23. Berndsen F, Arvidsson D, Enander LK, Leijonmarck CE, Win- nendaal N, Weyhe D, Wijsmuller AR (2018) International gren U, Rudberg C, Smedberg S, Wickbom G, Montgomery A guidelines for groin hernia management. Hernia. https://doi.org/ (2002) Postoperative convalescence after inguinal hernia surgery: 10.1007/s10029-017-1668-x prospective randomized multicenter study of laparoscopic versus 7. Shouldice EB (2003) The Shouldice repair of groin hernias. Surg shouldice inguinal hernia repair in 1042 patients. Hernia 2:56–61 Clin N Am 83:1163–1187. https://doi.org/10.1016/S0039- 24. Arvidsson D, Berndsen FH, Larsson LG, Leijonmarck CE, Rim- 6109(03)00121-X ba ¨ck G, Rudberg C, Smedberg S, Spangen L, Montgomery A 8. Shouldice EB (2010) Surgery illustrated—surgical atlas the (2005) Randomized clinical trial comparing 5-year recurrence rate shouldice natural tissue repair for inguinal hernia. BJU Int after laparoscopic versus Shouldice repair of primary inguinal 105:428–439. https://doi.org/10.1111/j.1464-410X.s009.09155.x hernia. Br J Surg 92:1085–1091. https://doi.org/10.1002/bjs.5137 9. Fischer JE (2013) Hernia repair: why do we continue to perform 25. Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE, mesh repair in the face of the human toll of inguinodynia? Am J Rudberg C, Smedberg S, Montgomery A (2007) Discomfort five Surg 206:619–623. https://doi.org/10.1016/j.amjsurg.2013.03.010 years after laparoscopic and Shouldice inguinal hernia repair: a 10. Shouldice Hospital (2016) www.shouldice.com/the-shouldice- randomized trial with 867 patients. A report from the SMIL study hernia-repair-surgery.html group. Hernia 11:307–313. https://doi.org/10.1007/s10029-007- 11. Malik A, Bell CM, Stukel TA, Urbach DR (2016) Recurrence of 0214-7 inguinal hernias repaired in a large hernia surgical specialty 26. Bittner R, Sauerland S, Schmedt CG (2005) Comparison of hospital and general hospitals in Ontario, Canada. Can J Surg endoscopic techniques vs Shouldice and other open nonmesh 1:19–25. https://doi.org/10.1503/cjs.003915 techniques for inguinal hernia repair: a meta-analysis of ran- 12. Stechemesser B, Jacob DA, Schug-Paß C, Ko ¨ ckerling F (2012) domized controlled trials. Surg Endosc 5:605–615 Herniamed: an internet-based registry for outcome research in 27. Amato B, Moja L, Panico S, Persico G, Rispoli C, Rocco N, hernia surgery. Hernia 16:269–276. https://doi.org/10.1007/ Moschetti I (2012) Shouldice technique versus other open tech- s10029-012-0908-3 niques for inguinal hernia repair. Cochrane Database Syst Rev 13. Kockerling F, Simons T, Hukauf M, Hellinger A, Fortelny R, 18:CD001543. https://doi.org/10.1002/14651858.cd001543.pub4 Reinpold W, Bittner R (2017) The importance of registries in the 28. Hannan EL, Cozzens K, King SB et al (2012) The New York postmarketing surveillance of surgical meshes. Ann Surg. https:// State Cardiac Registries: history, contributions, limitations, and doi.org/10.1097/SLA.0000000000002326 lessons for future efforts to assess and publicly report healthcare 14. Lonjon G, Porcher R, Ergina P, Fouet M (2017) Boutron i outcomes. JACC 59:2309–2316 potential pitfalls of reporting and bias in observational studies 29. Ko ¨ ckerling F, Koch A, Lorenz R, Schug-Pass C, Stechemesser B, with propensity score analysis assessing a surgical procedure. Reinpold W (2015) How long do we need to follow-up our hernia Ann Surg 265:901–909. https://doi.org/10.1097/SLA. patients to find the real recurrence rate? Front Surg 2:24. https:// 0000000000001797 doi.org/10.3389/surg.2015.00024 15. Haapaniemi S, Nilsson E (2002) Recurrence and pain three years after groin hernia repair. Validation of postal questionnaire and

Journal

World Journal of SurgerySpringer Journals

Published: Jan 3, 2018

References

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create lists to
organize your research

Export lists, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off