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High Complication Rate After Early Ileostomy Closure Prompts Study’s Halt

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In a prematurely stopped trial, ulcerative colitis patients with ileal pouch–anal anastomosis (IPAA) who underwent early closure of their diverting loop ileostomy experienced an unacceptably high rate of postoperative complications. The findings, reported at the 2022 annual meeting of the American Society of Colon and Rectal Surgeons, suggest that early closure of the ileostomy in this setting is not recommended, even when clinical and radiological assessment of the IPAA indicates that restoration of bowel continuity may be safely performed.

The SLIRPS (Short Versus Long Interval to Ileostomy Reversal After Pouch Surgery) trial was a multicenter, prospective, randomized trial that tested early (seven to 12 days) compared with late (eight weeks or more) closure of the diverting ileostomy after two- or three-stage IPAA in adults with ulcerative colitis. The trial was conducted by colorectal surgeons in the Crohn’s and Colitis Foundation surgical research network and led by Jon Vogel, MD, a colorectal surgeon at UCHealth in Aurora, Colo.

Patients who passed both a clinical and radiological assessment of their IPAA were randomized to early or late closure of their diverting ileostomy. The primary outcome was the comprehensive complication index at 30 days after ileostomy closure. Secondary outcomes were total complications, complication severity, reoperation and readmission at 30 days after ileostomy closure.

The trial was stopped prematurely after interim analysis revealed a high rate of complications in the early closure group. Among 36 patients analyzed, one patient had an unplanned proctectomy with end ileostomy. Of the remaining 35 patients who underwent IPAA and diverting ileostomy, 28 (80%) were clinically eligible for early closure and underwent radiological IPAA assessment. Among these patients, there were three radiological failures including two with abscess/leak and one with pelvic hematoma. Of the 25 patients who passed both clinical and radiological assessment, 22 (88%) were randomized to early (n=10) or late closure (n=12), and 12% were excluded due to protocol violations. Median complication index was 14.8 and 0 after early and late closure, respectively (P=0.02).

One or more complications occurred in 70% of patients after early closure and 25% after late closure (P=0.035), and were severe in 30% and 0% of patients, respectively (P=0.041). Reoperation was required in 20% of the early closure cohort compared with 0% in the late closure cohort (P=0.10). Readmission was required in 70% in the early closure cohort and 8.3% in the late closure cohort (P=0.003). The full list of complications can be seen in the Table.

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Schedule1 Oct 2023