BACKGROUND Despite the emerging knowledge about colorectal anastomotic leakage (CAL) through the increasing number of clinical and experimental studies, there is no generally accepted definition of CAL. Because of the wide variety of definitions used in literature, comparison of study outcomes and quality of care is complicated. AIM To reach consensus on the definition of CAL using a modified Delphi method. METHODS The RAND/UCLA appropriateness method was used. The expert panel consisted of international colorectal surgeons and researchers who had published three or more articles about CAL. The consensus process consisted of two online distributed questionnaires and a third round with a recommendation. In the questionnaires participants were asked to rate the appropriateness of statements using a 1-9 Likert scale. Consensus was defined as a panel median between 1-3 or 7-9 without disagreement. In the final round a recommendation was formed regarding the definition of CAL and the expert panel was asked if they agreed or disagreed. RESULTS Twenty-three authors participated in the first round and twenty-one finished the second round. After two rounds consensus was reached on 37 items (80%) in nine different categories. The International Study Group of Rectal Cancer definition is the most frequently advised general definition by our panel. Consensus was reached regarding the clinical symptoms of CAL, which serum markers contributes to the suspicion of CAL, which radiological and perioperative findings should be considered as CAL, which grading system is appropriate and if there should be a range of postoperative days in the definition. Eventually, 19 experts completed all three rounds of which 16 (84%) agreed with our final recommendations for the definition of CAL. CONCLUSION A consensus-based recommendation for the definition of CAL was formed using our modified Delphi method that can be widely incorporated in the field.

Background Anastomotic leakage (AL) is still a common and feared complication after low anterior resection (LAR) for rectal cancer. The multifactorial pathophysiology of AL and lack of standardised treatment options requires a multi-modal approach to improve long-term anastomotic integrity. The objective of the IMARI-trial is to determine whether the one-year anastomotic integrity rate in patients undergoing LAR for rectal cancer can be improved using a multi-interventional program. Methods IMARI is a multicentre prospective clinical effectiveness trial, whereby current local practice (control cohort) will be evaluated, and subsequently compared to results after implementation of the multi-interventional program (intervention cohort). Patients undergoing LAR for rectal cancer will be included. The multi-interventional program includes three preventive interventions (mechanical bowel preparation with oral antibiotics, tailored full splenic flexure mobilization and intraoperative fluorescence angiography using indocyanine green) combined with a standardised pathway for early detection and active management of AL. The primary outcome is anastomotic integrity, confirmed by CT-scan at one year postoperatively. Secondary outcomes include incidence of AL, protocol compliance and association with AL, temporary and permanent stoma rate, reintervention rate, quality of life and functional outcome. Microbiome analysis will be conducted to investigate the role of the rectal microbiome in AL. In a Dutch nationwide study, the AL rate was 20%, with anastomotic integrity of 90% after one year. Based on an expected reduction of AL due to the preventive approaches of 50%, and increase of anastomotic integrity by a standardised pathway for early detection and active management of AL, we hypothesised that the anastomotic integrity rate will increase from 90 to 97% at one year. An improvement of 7% in anastomotic integrity at one year was considered clinically relevant. A total number of 488 patients (244 per cohort) are needed to detect this difference, with 80% statistical power. Discussion The IMARI-trial is designed to evaluate whether a multi-interventional program can improve long-term anastomotic integrity after rectal cancer surgery. The uniqueness of IMARI lies in the multi-modal design that addresses the multifactorial pathophysiology for prevention, and a standardised pathway for early detection and active treatment of AL. Trial registration Trialregister.nl (NL8261), January 2020.

Purpose Highly selective fecal diversion after low anterior resection (LAR) for rectal cancer requires a strict postoperative protocol for early detection of anastomotic leakage (AL). The purpose of this study was to evaluate C-reactive protein (CRP)–based CT imaging in diagnosis and subsequent management of AL. Methods All patients that underwent a CT scan for suspicion of AL after transanal total mesorectal excision for rectal cancer in a university center (2015–2020) were included. Outcome parameters were diagnostic yield of CT and timing of CT and subsequent intervention. Results Forty-four out of 125 patients underwent CT (35%) with an overall median interval of 5 h (IQR 3–6) from CRP measurement. The anastomosis was diverted in 7/44 (16%). CT was conclusive or highly suspicious for AL in 23, with confirmed AL in all those patients (yield 52%), and was false-negative in one patient (sensitivity 96%). CT initiated subsequent intervention after median 6 h (IQR 3–25). There was no or minor suspicion of AL on imaging in all 20 patients without definitive diagnosis of AL. After CT imaging on day 2, AL was confirmed in 0/1, and these proportions were 6/6 for day 3, 7/10 for day 4, 2/4 for day 5, and 9/23 beyond day 5. Conclusion In the setting of an institutional policy of highly selective fecal diversion and pro-active leakage management, the yield of selective CT imaging using predefined CRP cut-off values was 52% with a sensitivity of 96%, enabling timely and tailored intervention after a median of 6 h from imaging.