Changes in Clinical Practice Reduce the Rate of Anastomotic Leakage After Colorectal Resections

Changes in Clinical Practice Reduce the Rate of Anastomotic Leakage After Colorectal Resections Background Anastomotic leakage is a serious clinical problem after colorectal resections and is associated with a significantly increased length of stay, morbidity and mortality. The aim of the present study was to evaluate the effect of changes in clinical practice on anastomotic leakage rate after colorectal resections. Methods Retrospective cohort study based on prospectively collected data. All 894 patients with primary anasto- mosis after colorectal resection at a tertiary referral center between 2006 and 2013 were analyzed. Changes in clinical practice aiming at reducing the rate of anastomotic leakages were introduced in January 2010 and were characterized by exclusion of perioperative nonsteroidal anti-inflammatory drugs, introduction of intra-operative goal-directed fluid therapy and avoidance of primary anastomoses in emergency resections. The study population was divided into two groups, one treated before and one after the introduction of changes in clinical practice. Groups were compared regarding patient characteristics and incidence of anastomotic leakage. Results The cumulative incidence of anastomotic leakage after colorectal resections decreased from 10.0% (41 of 409) to 4.5% (22 of 485) after changing clinical practice, relative risk 0.45 (95% CI 0.27–0.75, p = 0.002). The adjusted odds ratio was 0.45 (0.26–0.78, p = 0.004). A separate analysis showed a decrease after colon resections from 9.1% (23 of 252) to 4.5% (14 of 310), relative risk 0.49 (0.26–0.94, p = 0.039), and from 11.5% (18 of 157) to 4.6% (8 of 175) after rectal resections, relative risk 0.40 (0.18–0.89, p = 0.024). Conclusion Implementing a structured change of clinical practice can significantly reduce the anastomotic leakage rate after colorectal resections. Trial registration Clinical trial registration number: ACTRN12617001497392. Introduction Anastomotic leakage after colorectal surgery is a serious complication which is associated with severe morbidity, increased length of stay and overall mortality [1–4]. The & Henrik Iversen henrik.iversen@sll.se reported incidence of anastomotic leakage varies between 1.8 and 19%, typically higher in low rectal anastomoses Department of Molecular Medicine and Surgery, Karolinska and in randomized or population-based studies [2, 4–6]. Institutet and Center for Digestive Diseases, Karolinska Several risk factors for anastomotic leakage are not University Hospital, Solna, P9:03, 17176 Stockholm, Sweden 2 adjustable, and the potentially adjustable factors are diffi- Department of Physiology and Pharmacology, Karolinska cult to affect by the surgeon [2, 3, 7]. Institutet and Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Stockholm, Sweden 123 World J Surg (2018) 42:2234–2241 2235 In 2009 the first reports were published indicating that clinical practice aiming at reducing the anastomotic leak- nonsteroidal anti-inflammatory drugs (NSAIDs) may have age rate were introduced in January 2010. Cumulative a detrimental effect on colorectal anastomotic healing in incidence of anastomotic leakage was the primary outcome patients [8]. Currently, the effect of NSAIDs on anasto- and compared between patients treated before (period 1: motic healing has not been assessed in a large randomized 2006–2009) and after (period 2: 2010–2013) implementing controlled trial. A recent meta-analysis, however, suggests the changes in clinical practice. caution when prescribing NSAIDs to patients with preex- isting risk factors for anastomotic leakage [9]. Changes in clinical practice Intra-operative goal-directed fluid therapy improves outcomes in major surgery and has been shown to reduce Changes in clinical practice aiming at reducing the risk of postoperative morbidity and length of stay [10–12]. anastomotic leakage included three key elements: Emergency colon resection has been identified as an 1. NSAIDs were not allowed from 5 days before surgery independent risk factor for anastomotic leakages, and to 7 days after surgery. For patients with a history of defunctioning stoma reduces the incidence of clinically ischemic heart disease low dose (B75 mg daily) relevant anastomotic leakages after low anterior resection acetylsalicylic acid was, however accepted, irrespec- [2, 5, 13]. tive of EDA. Oral slow release opioids in combination Surgical skills and techniques affect oncological out- with naloxone replaced the NSAIDs. comes for patients operated for colorectal cancer [14]. The 2. Goal-directed intra-operative fluid therapy was man- principles of total mesorectal excision (TME) according to aged by stroke volume (SV) optimization using Heald were introduced at our institution in 1992, and TM esophageal Doppler (CardioQ-ODM ; Deltex Med- complete mesocolic excision (CME) according to Hohen- ical, Chichester, UK). Fluid loading was done using berger has been consistently applied since 2004 [15, 16]. A 200 ml of 6% hydroxyethyl starch solution or a standardized enhanced recovery program (ERP) was dextran 60 solution. If SV increased C10%, the fluid implemented in 2006 [17]. These measures improved challenge was considered positive and an additional oncological outcomes and decreased the length of stay. fluid bolus was given. After SV optimization was However, we considered the incidence of anastomotic achieved, the epidural was activated. During the course leakage after colorectal resections being unsatisfactory of surgery, optimization maneuvers were repeated at high. In an attempt to reduce the leakage rate after col- the discretion of the anaesthetist. orectal resections changes in clinical practice were intro- 3. Surgeons were instructed to avoid emergency onco- duced at the Section for Coloproctology at the Karolinska logical resections of obstructing cancers by instead University Hospital in 2010. performing temporary defunctioning ostomies. Pri- The hypothesis was that exclusion of perioperative mary anastomosis was not recommended if an emer- NSAIDs, introduction of intra-operative goal-directed fluid gency resection was unavoidable (i.e., bowel therapy and avoidance of primary anastomoses in emer- perforation, ischemia or severe bleeding). gency resections would reduce the incidence of anasto- motic leakage. The aim of this cohort study was to assess the combined Data source and definition of anastomotic leakage effect of these changes in clinical practice on the incidence of anastomotic leakage. The same research nurse recorded data prospectively throughout the whole study period on sex, age, diagnosis, surgical procedure, length of stay, elective/emergency Methods surgery, type of complications (including anastomotic leakage) and surgical re-interventions in a dedicated data- Study design, setting and participants base. Computed tomography with rectal contrast enema was the standard examination in patients with a deviant This is a cohort study that included all consecutive patients postoperative course and was liberally performed. Occur- treated with colon or rectal resection and primary anasto- rence of anastomotic leakage was registered during index mosis at the Karolinska University Hospital, a tertiary hospital stay or 30 days postoperatively. Visible signs of an referral center, between January 2006 and December 2013. anastomotic defect during reoperation, leakage of luminal Colorectal resections were performed with standardized contrast on radiological assessment or need for percuta- neous drainage of any intraabdominal fluid collection near mainly open surgery during the study. Surgical principles, preoperative and postoperative care remained unchanged the anastomotic site was regarded as anastomotic leakage. during the entire study period. Structured changes in Anastomotic leakage was thus defined according to the 123 2236 World J Surg (2018) 42:2234–2241 International Study Group of Rectal Cancer as a defect of peritonitis a laparotomy was performed. In severe cases the the intestinal wall at the anastomotic site (including suture anastomosis was taken down and a descending colostomy and staple lines of neorectal reservoirs) leading to a com- created. In cases of limited pelvic sepsis with only a minor munication between the intra- and extraluminal compart- anastomotic defect a protective ileostomy was created if ments, or as an abscess adjacent to the anastomosis [18]. not already present. Patients with anastomotic leakage after Early postoperative radiology with rectal contrast enema colonic resections were managed similarly, but the anas- was not routinely performed for all patients. This was only tomosis was more likely taken down with a creation of a performed in case of a deviant postoperative course, e.g., deviating ostomy. However, if bowel continuity was pre- leukocytosis or fever. Hence, only grade B and C leakages sent and sepsis well confined to an abscess adjacent to the requiring any therapeutic intervention were included in this anastomosis the patient could be managed more conser- trial. vatively with percutaneous drainage and antibiotics. The management of anastomotic leakage was the same during Surgical techniques the whole study period. Anterior resection implied TME surgery with transection Enhanced recovery protocol of the inferior mesenteric artery (IMA) [19, 20] with ligation of the inferior mesenteric vein and the left colic All electively treated study participants were included in artery at the same level. The marginal artery and terminal the ERP, implemented in January 2006. The ERP included bifurcation of the ascending left colic artery were spared in preoperative carbohydrate-rich beverage, intra-operative -1 order to preserve adequate blood supply to the descending buffered glucose solution (25 mg ml ) at a rate of -1 -1 colon in case of an insufficient marginal artery at the 2–3 ml kg h to replace insensible loss and nore- splenic flexure [21]. The left colon was divided after pinephrine to achieve a mean arterial pressure of above complete mobilization of the splenic flexure in order to 60–70 mm Hg. Oral bowel preparation was restricted to resect the sigmoid together with the specimen. The ratio- patients scheduled for anterior resection. For analgesia, a nale for a complete resection of the sigmoid colon was to low thoracic epidural catheter was inserted before induc- obtain a better anastomotic blood perfusion, since dividing tion of anesthesia and celecoxib, a selective cyclooxyge- the IMA results in a decreased arterial perfusion in the nase (COX) 2 inhibitor, was routinely used for sigmoid colon which may decrease tissue oxygenation in postoperative pain management. the proximal limb and hence increase the risk of anasto- motic leakage [22–24]. Before transecting the colon the Statistics marginal artery and vasa recta supplying the proximal staple line were indentified and preserved. A stapled side- Study data were recorded in a dedicated database and to-end colorectal anastomosis was performed [25, 26]. analyzed by Stata version 12 (StataCorp LP, College Sta- Except for non-irradiated women without other risk factors tion, TX, USA). Groups were compared with nonpara- a defunctioning loop ileostomy was recommended. In metric tests and Fisher’s exact tests. Univariable logistic sigmoid resections the IMA was divided at its origin, the regression was used to assess the crude effect of study bowel transected at the level of the promontory and the period and other predictors on anastomotic leakage. anastomosis was stapled. In right-sided colectomies the Potential confounding and/or effect modulation of age, sex, ileocolic vessels were divided at their origin together with type of resection (colonic versus rectal), type of pathology the right branch of the middle colic artery after identifi- (diagnosis), simultaneous (multivisceral) resections, acute cation of the superior mesenteric vein. Anastomoses were or elective surgery and protective ostomy was assessed hand sewn or stapled. The splenic flexure was resected and with multivariable logistic regression analysis. Covariates the middle colic artery divided at its origin in extended that changed the unadjusted odds ratio (OR) by more than right-sided colectomies or resections of the transverse 10% were regarded as important predictors and included in colon. the final model to report adjusted OR. Interaction terms There were no changes in operative techniques in period with a p value below 0.05 were regarded as significant. 2 compared to period 1. Management of anastomotic leakage Symptomatic anastomotic leakages with no sign of fecal peritonitis were managed by transanal or percutaneous drainage and antibiotics. If there were signs of fecal 123 World J Surg (2018) 42:2234–2241 2237 displays the cumulative incidence of anastomotic leakage Results per year. The incidence decreased after the introduction of Participants the changes in clinical practice, and the highest value in period 2 was consistently lower than the lowest value in The reason for surgery did not change between the two period 1. time periods and were colorectal neoplasia in 85%, inflammatory bowel disease (IBD) in 13% and other Logistic regression analysis pathology in 2%. Age, sex, type of resection, the propor- tion of multivisceral resections and protective ostomies The logistic regression resulted in an unadjusted OR for anastomotic leakage of 0.43 (95% CI 0.25–0.73, were similar in both groups (Table 1). The proportion of p = 0.002) for all patients operated with colorectal resec- emergency resections decreased significantly from 14 to tions in period 2 versus period 1 (Table 3). The crude 4% (p \ 0.01) in colon resections and from 4% to zero effect of age, sex, type of resection, type of pathology, (p = 0.01) in rectal resections (Table 1). multivisceral resection, acute surgery and protecting ost- omy on anastomotic leakage was statistically not signifi- Cumulative incidence of anastomotic leakage cant. The multivariable logistic regression indicated no confounding effect of the predictors above, nor were their The cumulative incidence of anastomotic leakage was 10.0% (41 of 409) before the change in clinical practice interaction terms significant. The model adjusted for age, sex, type of resection and acute surgery resulted in an OR (period 1) and decreased to 4.5% (22 of 485) after the of 0.45 (95% CI 0.26–0.78, p = 0.004). The multivariable change in clinical practice (period 2) with a relative risk analysis restricted to elective colorectal procedures yielded (RR) for anastomotic leakage of 0.45 (95% CI 0.27–0.75, an OR of 0.47 (95% CI 0.27–0.82, p = 0.007) after p = 0.002). For colon resections the cumulative incidence adjustment for age, sex, type of resection and acute decreased from 9.1% (23 of 252) to 4.5% (14 of 310) and surgery. for rectal resections from 11.5% (18 of 157) to 4.6% (8 of 175). The relative risk was 0.49 (95% CI 0.26–0.94, Length of stay p = 0.039) for colon and 0.40 (95% CI 0.18–0.89, p = 0.024) for rectal resections, respectively (Table 2). The median length of stay for participants with an anas- The effect of the changes in clinical practice was similar in the analysis restricted to elective colorectal resections tomotic leakage was longer; 25 (6–190) days versus 9 (2–167) days, (p \ 0.001) in the entire study population. with RR 0.47 (95% CI 0.28–0.79, p = 0.004). Figure 1 Table 1 Characteristics of patients with primary anastomosis after colorectal resections Variable Period 1 (n = 409) Period 2 (n = 485) p value Sex ratio (M:F) 234:175 262:223 0.35 Age* (years) 66 (26–89) 65 (17–97) 0.54 Type of pathology 0.69 Cancer 347 (85) 412 (85) IBD 55 (13) 61 (13) Other 7 (2) 12 (2) Type of resection 0.49 Colon 252 (62) 310 (64) Rectal 157 (38) 175 (36) Multivisceral resection 128 (31) 163 (34) 0.47 Protective ostomy Colon 21 (8) 26 (8) 1.00 Rectum 116 (74) 137 (78) 0.39 Emergency resection Colon 36 (14) 11 (4) \0.01 Rectum 6 (4) 0 (0) 0.01 Period 1 (2006–2009) versus period 2 (2010–2013), after introduction of changes in clinical practice aiming at reducing anastomotic leakages Values in parentheses are percentages. p value Fisher’s exact. *Wilcoxon rank-sum test 123 2238 World J Surg (2018) 42:2234–2241 Table 2 Cumulative incidence of anastomotic leakage after colorectal resections with primary anastomosis Type of resection Period 1 Period 2 p value n Leakage n Leakage RR (CI) Colon and rectum 409 41 (10.0) 485 22 (4.5) 0.45 (0.27–0.75) 0.002 Colon 252 23 (9.1) 310 14 (4.5) 0.49 (0.26–0.94) 0.039 Rectum 157 18 (11.5) 175 8 (4.6) 0.40 (0.18–0.89) 0.024 Period 1 (2006–2009) versus period 2 (2010–2013), after changing clinical practice aiming at reducing anastomotic leakages Values in parentheses are percentages. RR relative risk, CI confidence interval. p value Fisher’s exact Fig. 1 Cumulative incidence of anastomotic leakage per year for patients with primary anastomosis after colorectal resections. Changes in clinical practice aiming at reducing anastomotic leakages were introduced in 2010 The median length of stay was shorter after the introduc- an independent risk factor for anastomotic leakage [2]. The tion of changes in clinical practice; 9 (3–119) days versus proportion of emergency resections was small in the pre- 10 (2–190) days (p = 0.043) (Table 4). sent study which may explain why this effect was not detected, as analysis restricted to elective procedures showed similar findings as for the entire study population. Discussion Previous studies suggest that omission of perioperative NSAIDs and optimizing intra-operative fluid balance are This cohort study shows that the anastomotic leakage rate factors that may reduce the risk of anastomotic leakage after colorectal resections with a primary anastomosis [9, 27]. Intra-operative fluid and sodium overload has been decreased from 10.0 to 4.5% after implementing a struc- associated with increased hospital stay and complication rate, but can be prevented by restricted fluid therapy regi- tured change in clinical practice including exclusion of perioperative NSAIDs, introduction of intra-operative mens [28–30]. Also hypovolemia may increase complica- goal-directed fluid therapy and avoidance of primary tions. Different methods for goal-directed fluid therapy in anastomoses in acute resections. However, the present order to obtain better fluid balance have been described and study design cannot determine to what extent each com- seem to improve postoperative outcomes in terms of ponent contributed to the reduction in anastomotic leakage shorter length of stay and reduced complication rates [31], rate. and has been recommended as part of ERPs [32]. Eso- Avoiding colorectal anastomoses in emergency proce- phageal Doppler for intra-operative stroke volume opti- dures may prevent anastomotic leakage since emergency mization was introduced at our unit for colorectal surgery resection with primary anastomosis has been identified as and may allow for better hemodynamic control, especially 123 World J Surg (2018) 42:2234–2241 2239 Table 3 Non-adjusted logistic analysis of risk factors for anastomotic leakage Variable Odds ratio 95% confidence interval p value Men 1 (ref) Women 0.65 0.38–1.11 0.114 Age (years) 1.01 0.99–1.03 0.211 Pathology Cancer 1 (ref) IBD 0.81 0.36–1.81 0.603 Other n.a. n.a. n.a. Type of resection Colon 1 (ref) Rectal 1.21 0.72–2.03 0.482 No multivisceral resection 1 (ref) Multivisceral resection 1.50 0.89–2.53 0.128 Elective resection 1 (ref) Emergency resection 1.40 0.54–3.66 0.489 No protective ostomy 1 (ref) Protective ostomy 0.78 0.44–1.37 0.386 Period 1 (2006–2009) 1 (ref) Period 2 (2010–2013) 0.43 0.25–0.73 0.002 Period 1 and period 2 are referring to before and after introduction of changes in clinical practice n.a. = not applicable due to no events The risk of selection bias was minimized by inclusion of all Table 4 Median length of stay for patients operated with colorectal consecutive patients undergoing colorectal resection with resections in period 1 versus period 2, and for patients with versus without anastomotic leakage primary anastomosis. During the entire study period the referral pattern did not change and patients treated before Group n LOS Range p and after the changes in clinical practice were comparable Period 1 409 10 2–190 regarding age, sex, type of diagnosis, type of resection, Period 2 485 9 3–119 0.043 multivisceral resection and protective ostomy. Principles of Leakage 63 25 6–190 care, except from the described changes in clinical practice, No leakage 831 9 2–167 \0.001 and senior medical staff remained unchanged during the study period. An overestimation of NSAIDs use during Median length of stay (LOS). p value Wilcoxon rank-sum test period 1 and goal-directed fluid therapy during period 2 cannot be excluded but would bias the presented estimates during longer and more complex surgery [33]. The com- toward no effect. Preoperative irradiation has been identi- bined effect of the factors above appeared to have an effect fied in some studies as an independent risk factor for in the present study and can be adopted at relatively low anastomotic leakage after low anterior resection [7, 36], costs. In contrast, the cost of grade III complications after while other studies have not [37]. The present study is colorectal operations has been estimated to a mean of more based on a local quality database without information about than 50,000 US Dollars [34]. Our results are in agreement neo-adjuvant treatment. A majority of the patients operated with a recent smaller study that reported a reduction in with low anterior resection were operated for rectal cancer anastomotic leakage rate from 9.8 to 4.2% after imple- (85%). Approximately 75% of these patients, irrespectively mentation of a very similar quality improvement program of period, received preoperative radiotherapy according to [35]. the national Swedish colorectal cancer register. Increased attention of involved surgeons to the problem of anasto- Limitations motic leakage, especially at the time of the introduction of changes in clinical practice, may have improved the results The majority of patients referred to the Karolinska in period 2 but cannot be quantified. Preoperative inter- University Hospital have advanced colorectal cancer or vention for smoking cessation seems to reduce the risk for complex inflammatory bowel disease, which is reflected by postoperative complications, but the policy regarding a high proportion of simultaneous multivisceral resections. 123 2240 World J Surg (2018) 42:2234–2241 smoking cessation did not change during the study period References [38]. Age, sex, type of resection, type of pathology, mul- 1. 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Changes in Clinical Practice Reduce the Rate of Anastomotic Leakage After Colorectal Resections

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Medicine & Public Health; Surgery; Abdominal Surgery; Cardiac Surgery; General Surgery; Thoracic Surgery; Vascular Surgery
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Abstract

Background Anastomotic leakage is a serious clinical problem after colorectal resections and is associated with a significantly increased length of stay, morbidity and mortality. The aim of the present study was to evaluate the effect of changes in clinical practice on anastomotic leakage rate after colorectal resections. Methods Retrospective cohort study based on prospectively collected data. All 894 patients with primary anasto- mosis after colorectal resection at a tertiary referral center between 2006 and 2013 were analyzed. Changes in clinical practice aiming at reducing the rate of anastomotic leakages were introduced in January 2010 and were characterized by exclusion of perioperative nonsteroidal anti-inflammatory drugs, introduction of intra-operative goal-directed fluid therapy and avoidance of primary anastomoses in emergency resections. The study population was divided into two groups, one treated before and one after the introduction of changes in clinical practice. Groups were compared regarding patient characteristics and incidence of anastomotic leakage. Results The cumulative incidence of anastomotic leakage after colorectal resections decreased from 10.0% (41 of 409) to 4.5% (22 of 485) after changing clinical practice, relative risk 0.45 (95% CI 0.27–0.75, p = 0.002). The adjusted odds ratio was 0.45 (0.26–0.78, p = 0.004). A separate analysis showed a decrease after colon resections from 9.1% (23 of 252) to 4.5% (14 of 310), relative risk 0.49 (0.26–0.94, p = 0.039), and from 11.5% (18 of 157) to 4.6% (8 of 175) after rectal resections, relative risk 0.40 (0.18–0.89, p = 0.024). Conclusion Implementing a structured change of clinical practice can significantly reduce the anastomotic leakage rate after colorectal resections. Trial registration Clinical trial registration number: ACTRN12617001497392. Introduction Anastomotic leakage after colorectal surgery is a serious complication which is associated with severe morbidity, increased length of stay and overall mortality [1–4]. The & Henrik Iversen henrik.iversen@sll.se reported incidence of anastomotic leakage varies between 1.8 and 19%, typically higher in low rectal anastomoses Department of Molecular Medicine and Surgery, Karolinska and in randomized or population-based studies [2, 4–6]. Institutet and Center for Digestive Diseases, Karolinska Several risk factors for anastomotic leakage are not University Hospital, Solna, P9:03, 17176 Stockholm, Sweden 2 adjustable, and the potentially adjustable factors are diffi- Department of Physiology and Pharmacology, Karolinska cult to affect by the surgeon [2, 3, 7]. Institutet and Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Stockholm, Sweden 123 World J Surg (2018) 42:2234–2241 2235 In 2009 the first reports were published indicating that clinical practice aiming at reducing the anastomotic leak- nonsteroidal anti-inflammatory drugs (NSAIDs) may have age rate were introduced in January 2010. Cumulative a detrimental effect on colorectal anastomotic healing in incidence of anastomotic leakage was the primary outcome patients [8]. Currently, the effect of NSAIDs on anasto- and compared between patients treated before (period 1: motic healing has not been assessed in a large randomized 2006–2009) and after (period 2: 2010–2013) implementing controlled trial. A recent meta-analysis, however, suggests the changes in clinical practice. caution when prescribing NSAIDs to patients with preex- isting risk factors for anastomotic leakage [9]. Changes in clinical practice Intra-operative goal-directed fluid therapy improves outcomes in major surgery and has been shown to reduce Changes in clinical practice aiming at reducing the risk of postoperative morbidity and length of stay [10–12]. anastomotic leakage included three key elements: Emergency colon resection has been identified as an 1. NSAIDs were not allowed from 5 days before surgery independent risk factor for anastomotic leakages, and to 7 days after surgery. For patients with a history of defunctioning stoma reduces the incidence of clinically ischemic heart disease low dose (B75 mg daily) relevant anastomotic leakages after low anterior resection acetylsalicylic acid was, however accepted, irrespec- [2, 5, 13]. tive of EDA. Oral slow release opioids in combination Surgical skills and techniques affect oncological out- with naloxone replaced the NSAIDs. comes for patients operated for colorectal cancer [14]. The 2. Goal-directed intra-operative fluid therapy was man- principles of total mesorectal excision (TME) according to aged by stroke volume (SV) optimization using Heald were introduced at our institution in 1992, and TM esophageal Doppler (CardioQ-ODM ; Deltex Med- complete mesocolic excision (CME) according to Hohen- ical, Chichester, UK). Fluid loading was done using berger has been consistently applied since 2004 [15, 16]. A 200 ml of 6% hydroxyethyl starch solution or a standardized enhanced recovery program (ERP) was dextran 60 solution. If SV increased C10%, the fluid implemented in 2006 [17]. These measures improved challenge was considered positive and an additional oncological outcomes and decreased the length of stay. fluid bolus was given. After SV optimization was However, we considered the incidence of anastomotic achieved, the epidural was activated. During the course leakage after colorectal resections being unsatisfactory of surgery, optimization maneuvers were repeated at high. In an attempt to reduce the leakage rate after col- the discretion of the anaesthetist. orectal resections changes in clinical practice were intro- 3. Surgeons were instructed to avoid emergency onco- duced at the Section for Coloproctology at the Karolinska logical resections of obstructing cancers by instead University Hospital in 2010. performing temporary defunctioning ostomies. Pri- The hypothesis was that exclusion of perioperative mary anastomosis was not recommended if an emer- NSAIDs, introduction of intra-operative goal-directed fluid gency resection was unavoidable (i.e., bowel therapy and avoidance of primary anastomoses in emer- perforation, ischemia or severe bleeding). gency resections would reduce the incidence of anasto- motic leakage. The aim of this cohort study was to assess the combined Data source and definition of anastomotic leakage effect of these changes in clinical practice on the incidence of anastomotic leakage. The same research nurse recorded data prospectively throughout the whole study period on sex, age, diagnosis, surgical procedure, length of stay, elective/emergency Methods surgery, type of complications (including anastomotic leakage) and surgical re-interventions in a dedicated data- Study design, setting and participants base. Computed tomography with rectal contrast enema was the standard examination in patients with a deviant This is a cohort study that included all consecutive patients postoperative course and was liberally performed. Occur- treated with colon or rectal resection and primary anasto- rence of anastomotic leakage was registered during index mosis at the Karolinska University Hospital, a tertiary hospital stay or 30 days postoperatively. Visible signs of an referral center, between January 2006 and December 2013. anastomotic defect during reoperation, leakage of luminal Colorectal resections were performed with standardized contrast on radiological assessment or need for percuta- neous drainage of any intraabdominal fluid collection near mainly open surgery during the study. Surgical principles, preoperative and postoperative care remained unchanged the anastomotic site was regarded as anastomotic leakage. during the entire study period. Structured changes in Anastomotic leakage was thus defined according to the 123 2236 World J Surg (2018) 42:2234–2241 International Study Group of Rectal Cancer as a defect of peritonitis a laparotomy was performed. In severe cases the the intestinal wall at the anastomotic site (including suture anastomosis was taken down and a descending colostomy and staple lines of neorectal reservoirs) leading to a com- created. In cases of limited pelvic sepsis with only a minor munication between the intra- and extraluminal compart- anastomotic defect a protective ileostomy was created if ments, or as an abscess adjacent to the anastomosis [18]. not already present. Patients with anastomotic leakage after Early postoperative radiology with rectal contrast enema colonic resections were managed similarly, but the anas- was not routinely performed for all patients. This was only tomosis was more likely taken down with a creation of a performed in case of a deviant postoperative course, e.g., deviating ostomy. However, if bowel continuity was pre- leukocytosis or fever. Hence, only grade B and C leakages sent and sepsis well confined to an abscess adjacent to the requiring any therapeutic intervention were included in this anastomosis the patient could be managed more conser- trial. vatively with percutaneous drainage and antibiotics. The management of anastomotic leakage was the same during Surgical techniques the whole study period. Anterior resection implied TME surgery with transection Enhanced recovery protocol of the inferior mesenteric artery (IMA) [19, 20] with ligation of the inferior mesenteric vein and the left colic All electively treated study participants were included in artery at the same level. The marginal artery and terminal the ERP, implemented in January 2006. The ERP included bifurcation of the ascending left colic artery were spared in preoperative carbohydrate-rich beverage, intra-operative -1 order to preserve adequate blood supply to the descending buffered glucose solution (25 mg ml ) at a rate of -1 -1 colon in case of an insufficient marginal artery at the 2–3 ml kg h to replace insensible loss and nore- splenic flexure [21]. The left colon was divided after pinephrine to achieve a mean arterial pressure of above complete mobilization of the splenic flexure in order to 60–70 mm Hg. Oral bowel preparation was restricted to resect the sigmoid together with the specimen. The ratio- patients scheduled for anterior resection. For analgesia, a nale for a complete resection of the sigmoid colon was to low thoracic epidural catheter was inserted before induc- obtain a better anastomotic blood perfusion, since dividing tion of anesthesia and celecoxib, a selective cyclooxyge- the IMA results in a decreased arterial perfusion in the nase (COX) 2 inhibitor, was routinely used for sigmoid colon which may decrease tissue oxygenation in postoperative pain management. the proximal limb and hence increase the risk of anasto- motic leakage [22–24]. Before transecting the colon the Statistics marginal artery and vasa recta supplying the proximal staple line were indentified and preserved. A stapled side- Study data were recorded in a dedicated database and to-end colorectal anastomosis was performed [25, 26]. analyzed by Stata version 12 (StataCorp LP, College Sta- Except for non-irradiated women without other risk factors tion, TX, USA). Groups were compared with nonpara- a defunctioning loop ileostomy was recommended. In metric tests and Fisher’s exact tests. Univariable logistic sigmoid resections the IMA was divided at its origin, the regression was used to assess the crude effect of study bowel transected at the level of the promontory and the period and other predictors on anastomotic leakage. anastomosis was stapled. In right-sided colectomies the Potential confounding and/or effect modulation of age, sex, ileocolic vessels were divided at their origin together with type of resection (colonic versus rectal), type of pathology the right branch of the middle colic artery after identifi- (diagnosis), simultaneous (multivisceral) resections, acute cation of the superior mesenteric vein. Anastomoses were or elective surgery and protective ostomy was assessed hand sewn or stapled. The splenic flexure was resected and with multivariable logistic regression analysis. Covariates the middle colic artery divided at its origin in extended that changed the unadjusted odds ratio (OR) by more than right-sided colectomies or resections of the transverse 10% were regarded as important predictors and included in colon. the final model to report adjusted OR. Interaction terms There were no changes in operative techniques in period with a p value below 0.05 were regarded as significant. 2 compared to period 1. Management of anastomotic leakage Symptomatic anastomotic leakages with no sign of fecal peritonitis were managed by transanal or percutaneous drainage and antibiotics. If there were signs of fecal 123 World J Surg (2018) 42:2234–2241 2237 displays the cumulative incidence of anastomotic leakage Results per year. The incidence decreased after the introduction of Participants the changes in clinical practice, and the highest value in period 2 was consistently lower than the lowest value in The reason for surgery did not change between the two period 1. time periods and were colorectal neoplasia in 85%, inflammatory bowel disease (IBD) in 13% and other Logistic regression analysis pathology in 2%. Age, sex, type of resection, the propor- tion of multivisceral resections and protective ostomies The logistic regression resulted in an unadjusted OR for anastomotic leakage of 0.43 (95% CI 0.25–0.73, were similar in both groups (Table 1). The proportion of p = 0.002) for all patients operated with colorectal resec- emergency resections decreased significantly from 14 to tions in period 2 versus period 1 (Table 3). The crude 4% (p \ 0.01) in colon resections and from 4% to zero effect of age, sex, type of resection, type of pathology, (p = 0.01) in rectal resections (Table 1). multivisceral resection, acute surgery and protecting ost- omy on anastomotic leakage was statistically not signifi- Cumulative incidence of anastomotic leakage cant. The multivariable logistic regression indicated no confounding effect of the predictors above, nor were their The cumulative incidence of anastomotic leakage was 10.0% (41 of 409) before the change in clinical practice interaction terms significant. The model adjusted for age, sex, type of resection and acute surgery resulted in an OR (period 1) and decreased to 4.5% (22 of 485) after the of 0.45 (95% CI 0.26–0.78, p = 0.004). The multivariable change in clinical practice (period 2) with a relative risk analysis restricted to elective colorectal procedures yielded (RR) for anastomotic leakage of 0.45 (95% CI 0.27–0.75, an OR of 0.47 (95% CI 0.27–0.82, p = 0.007) after p = 0.002). For colon resections the cumulative incidence adjustment for age, sex, type of resection and acute decreased from 9.1% (23 of 252) to 4.5% (14 of 310) and surgery. for rectal resections from 11.5% (18 of 157) to 4.6% (8 of 175). The relative risk was 0.49 (95% CI 0.26–0.94, Length of stay p = 0.039) for colon and 0.40 (95% CI 0.18–0.89, p = 0.024) for rectal resections, respectively (Table 2). The median length of stay for participants with an anas- The effect of the changes in clinical practice was similar in the analysis restricted to elective colorectal resections tomotic leakage was longer; 25 (6–190) days versus 9 (2–167) days, (p \ 0.001) in the entire study population. with RR 0.47 (95% CI 0.28–0.79, p = 0.004). Figure 1 Table 1 Characteristics of patients with primary anastomosis after colorectal resections Variable Period 1 (n = 409) Period 2 (n = 485) p value Sex ratio (M:F) 234:175 262:223 0.35 Age* (years) 66 (26–89) 65 (17–97) 0.54 Type of pathology 0.69 Cancer 347 (85) 412 (85) IBD 55 (13) 61 (13) Other 7 (2) 12 (2) Type of resection 0.49 Colon 252 (62) 310 (64) Rectal 157 (38) 175 (36) Multivisceral resection 128 (31) 163 (34) 0.47 Protective ostomy Colon 21 (8) 26 (8) 1.00 Rectum 116 (74) 137 (78) 0.39 Emergency resection Colon 36 (14) 11 (4) \0.01 Rectum 6 (4) 0 (0) 0.01 Period 1 (2006–2009) versus period 2 (2010–2013), after introduction of changes in clinical practice aiming at reducing anastomotic leakages Values in parentheses are percentages. p value Fisher’s exact. *Wilcoxon rank-sum test 123 2238 World J Surg (2018) 42:2234–2241 Table 2 Cumulative incidence of anastomotic leakage after colorectal resections with primary anastomosis Type of resection Period 1 Period 2 p value n Leakage n Leakage RR (CI) Colon and rectum 409 41 (10.0) 485 22 (4.5) 0.45 (0.27–0.75) 0.002 Colon 252 23 (9.1) 310 14 (4.5) 0.49 (0.26–0.94) 0.039 Rectum 157 18 (11.5) 175 8 (4.6) 0.40 (0.18–0.89) 0.024 Period 1 (2006–2009) versus period 2 (2010–2013), after changing clinical practice aiming at reducing anastomotic leakages Values in parentheses are percentages. RR relative risk, CI confidence interval. p value Fisher’s exact Fig. 1 Cumulative incidence of anastomotic leakage per year for patients with primary anastomosis after colorectal resections. Changes in clinical practice aiming at reducing anastomotic leakages were introduced in 2010 The median length of stay was shorter after the introduc- an independent risk factor for anastomotic leakage [2]. The tion of changes in clinical practice; 9 (3–119) days versus proportion of emergency resections was small in the pre- 10 (2–190) days (p = 0.043) (Table 4). sent study which may explain why this effect was not detected, as analysis restricted to elective procedures showed similar findings as for the entire study population. Discussion Previous studies suggest that omission of perioperative NSAIDs and optimizing intra-operative fluid balance are This cohort study shows that the anastomotic leakage rate factors that may reduce the risk of anastomotic leakage after colorectal resections with a primary anastomosis [9, 27]. Intra-operative fluid and sodium overload has been decreased from 10.0 to 4.5% after implementing a struc- associated with increased hospital stay and complication rate, but can be prevented by restricted fluid therapy regi- tured change in clinical practice including exclusion of perioperative NSAIDs, introduction of intra-operative mens [28–30]. Also hypovolemia may increase complica- goal-directed fluid therapy and avoidance of primary tions. Different methods for goal-directed fluid therapy in anastomoses in acute resections. However, the present order to obtain better fluid balance have been described and study design cannot determine to what extent each com- seem to improve postoperative outcomes in terms of ponent contributed to the reduction in anastomotic leakage shorter length of stay and reduced complication rates [31], rate. and has been recommended as part of ERPs [32]. Eso- Avoiding colorectal anastomoses in emergency proce- phageal Doppler for intra-operative stroke volume opti- dures may prevent anastomotic leakage since emergency mization was introduced at our unit for colorectal surgery resection with primary anastomosis has been identified as and may allow for better hemodynamic control, especially 123 World J Surg (2018) 42:2234–2241 2239 Table 3 Non-adjusted logistic analysis of risk factors for anastomotic leakage Variable Odds ratio 95% confidence interval p value Men 1 (ref) Women 0.65 0.38–1.11 0.114 Age (years) 1.01 0.99–1.03 0.211 Pathology Cancer 1 (ref) IBD 0.81 0.36–1.81 0.603 Other n.a. n.a. n.a. Type of resection Colon 1 (ref) Rectal 1.21 0.72–2.03 0.482 No multivisceral resection 1 (ref) Multivisceral resection 1.50 0.89–2.53 0.128 Elective resection 1 (ref) Emergency resection 1.40 0.54–3.66 0.489 No protective ostomy 1 (ref) Protective ostomy 0.78 0.44–1.37 0.386 Period 1 (2006–2009) 1 (ref) Period 2 (2010–2013) 0.43 0.25–0.73 0.002 Period 1 and period 2 are referring to before and after introduction of changes in clinical practice n.a. = not applicable due to no events The risk of selection bias was minimized by inclusion of all Table 4 Median length of stay for patients operated with colorectal consecutive patients undergoing colorectal resection with resections in period 1 versus period 2, and for patients with versus without anastomotic leakage primary anastomosis. During the entire study period the referral pattern did not change and patients treated before Group n LOS Range p and after the changes in clinical practice were comparable Period 1 409 10 2–190 regarding age, sex, type of diagnosis, type of resection, Period 2 485 9 3–119 0.043 multivisceral resection and protective ostomy. Principles of Leakage 63 25 6–190 care, except from the described changes in clinical practice, No leakage 831 9 2–167 \0.001 and senior medical staff remained unchanged during the study period. An overestimation of NSAIDs use during Median length of stay (LOS). p value Wilcoxon rank-sum test period 1 and goal-directed fluid therapy during period 2 cannot be excluded but would bias the presented estimates during longer and more complex surgery [33]. The com- toward no effect. Preoperative irradiation has been identi- bined effect of the factors above appeared to have an effect fied in some studies as an independent risk factor for in the present study and can be adopted at relatively low anastomotic leakage after low anterior resection [7, 36], costs. In contrast, the cost of grade III complications after while other studies have not [37]. The present study is colorectal operations has been estimated to a mean of more based on a local quality database without information about than 50,000 US Dollars [34]. Our results are in agreement neo-adjuvant treatment. A majority of the patients operated with a recent smaller study that reported a reduction in with low anterior resection were operated for rectal cancer anastomotic leakage rate from 9.8 to 4.2% after imple- (85%). Approximately 75% of these patients, irrespectively mentation of a very similar quality improvement program of period, received preoperative radiotherapy according to [35]. the national Swedish colorectal cancer register. Increased attention of involved surgeons to the problem of anasto- Limitations motic leakage, especially at the time of the introduction of changes in clinical practice, may have improved the results The majority of patients referred to the Karolinska in period 2 but cannot be quantified. Preoperative inter- University Hospital have advanced colorectal cancer or vention for smoking cessation seems to reduce the risk for complex inflammatory bowel disease, which is reflected by postoperative complications, but the policy regarding a high proportion of simultaneous multivisceral resections. 123 2240 World J Surg (2018) 42:2234–2241 smoking cessation did not change during the study period References [38]. Age, sex, type of resection, type of pathology, mul- 1. 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World Journal of SurgerySpringer Journals

Published: Dec 28, 2017

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