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
Has another colorectal malignant tumor at the same time
The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
Has metastatic disease before surgery
Is pregnant
Tongji Hospital
Lead sponsor
Ezhou Central Hospital
Collaborator
Shanxi Bethune Hospital
Collaborator
Taihe Hospital affiliated to Hubei University of Medicine
Collaborator
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Collaborator