P1128Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch anal-anastomosis? The IDEAL trial

Abstract Background There is currently no high-level evidence supporting the routine use of a defunctioning ileostomy (DI) in ileal pouch–anal anastomosis (IPAA) for inflammatory bowel disease (IBD). This trial aimed to evaluate the necessity of systematic DI during completion proctectomy and IPAA in patients with IBD. Methods This multicenter, open-label, randomized superiority trial (NCT03872271), supported by the GETAID Chirurgie Group, compared IPAA performed with or without DI in patients with ulcerative or indeterminate colitis. Crohn’s disease was a non inclusion criterion. The primary endpoint was 6-month overall postoperative morbidity, including complications related to DI closure. Secondary endpoints included detailed 6-month morbidity (anastomotic leak, reoperation, readmission), functional outcomes and quality of life (QoL) at 3 and 12 months, along with 12-month pouch outcomes and overall morbidity. A planned safety analysis at mid-inclusion assessed leak rates. Results A total of 101 patients were enrolled. There were two screening failures, one patient early lost to follow-up, and one with a permanent stoma and no pouch. Ninety-seven patients were included in the interim safety analysis: 49 in the DI group and 48 in the no-DI group, with five crossovers. Baseline characteristics were comparable between groups, including ASA score (p = 0.74), sex (p = 0.07), and subtotal colectomy (STC) details, namely indication (p = 0.85), surgical approach (p = 0.41), and postoperative morbidity (p = 0.64). Intraoperative data were also similar between groups: surgical approach (laparoscopic/robotic: no-DI 61%/27% vs. DI 61%/19%, p = 0.72), type of anastomosis (stapled: no-DI 94% vs. DI 98%, p = 0.61), intraoperative complications (p = 0.75), operative time (p = 0.74), and conversion to open surgery (no-DI 10% vs. DI 6%, p = 0.71). In the intention-to-treat analysis, the anastomotic leak rate was significantly higher in the no-DI group (30.6% vs. 12.2%, p = 0.027), as were major morbidity (28.6% vs. 12.2%, p = 0.045) and length of hospital stay (10.7±5.8 vs. 7.1±4.0 days, p = 0.001). However, 6-month overall morbidity (the primary endpoint) was similar between groups (73.5% vs. 79.6%, p = 0.48), as were bowel obstruction and hematoma rates. The 6-month stoma rate was also comparable (4.1% vs. 0%, p = 0.50) and there were no deaths. In the per-protocol analysis, the anastomotic leak rate remained significantly higher in the no-DI group (32.6% vs. 13.0%, p = 0.026). Full 6- and 12-month results, including QoL and functional outcomes, will be presented. Conclusion IPAA without DI is associated with a significantly higher risk of anastomotic leakage. For safety reasons, the IDEAL trial was prematurely discontinued. References: Sahami S, Buskens CJ, Fadok TY, Tanis PJ, de Buck van Overstraeten A, Wolthuis AM, et al. Defunctioning Ileostomy is not Associated with Reduced Leakage in Proctocolectomy and Ileal Pouch Anastomosis Surgeries for IBD. J Crohn’s Colitis 2016;10:779-785. Zittan E, Wong-Chong N, Ma GW, McLeod RS, Silverberg MS, Cohen Z. Modified Two-stage Ileal Pouch-Anal Anastomosis Results in Lower Rate of Anastomotic Leak Compared with Traditional Two-stage Surgery for Ulcerative Colitis. J Crohn’s Colitis 2016;10:766-772. Samples J, Evans K, Chaumont N, Strassle P, Sadiq T, Koruda M. Variant Two-Stage Ileal Pouch-Anal Anastomosis: An Innovative and Effective Alternative to Standard Resection in Ulcerative Colitis. J Am Coll Surg 2017;224:557-563. Karjalainen EK, Renkonen-Sinisalo L, Mustonen HK, Lepistö AH. Morbidity related to diverting ileostomy after restorative proctocolectomy in patients with ulcerative colitis. Colorectal Dis. 2019;21:671-678. Conflict of interest: Prof. Beyer-Berjot, Laura: No conflict of interest Cotte, Eddy: No conflict of interest Benoist, Stephane: No conflict of interest Maggiori, Léon: No conflict of interest Brouquet, Antoine: No conflict of interest Denost, Quentin: No conflict of interest Lakkis, Zaher: No conflict of interest Desfourneaux, Virginie: No conflict of interest Zerbib, Philippe: No conflict of interest Germain, Adeline: No conflict of interest Vanbrugghe, Charles: No conflict of interest Ouaissi, Mehdi: No conflict of interest Berdah, Stéphane: No conflict of interest Boucekine, Mohamed: No conflict of interest Baumstarck, Karine: No conflict of interest Lefevre, Jeremie: No conflict of interest