Clinical Trial

Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection

Study acronym: SC-Stoma
Recruiting
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Summary
The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery. The main questions it aims to answer are: Does somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma? What medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up? Researchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation. Participants will: Have rectal cancer surgery with the bowel joined very close to the anus Be randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma Have follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life Complete follow-up visits or assessments for up to 3 years after surgery
Trial Details
NCT Number NCT07605611
Lead Sponsor Tongji Hospital
Collaborators: Ezhou Central Hospital, Shanxi Bethune Hospital, Taihe Hospital affiliated to Hubei University of Medicine, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Conditions Rectal Cancer, Anastomotic Leakage
Enrollment 72 participants
Start Date 2025-11-17
Primary Completion 2027-07-31 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-26