A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection
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
• Adults aged 18 to 75 years
• Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
• The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination
• The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
• Patients have two or more risk factors for anastomotic leakage as assessed by the study team
• American Society of Anesthesiologists physical status classification is grade 3 or lower
• Body mass index is less than 30 kg/m²
• The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent