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
Parallel
Somatostatin
DrugParticipants in the experimental arm will receive somatostatin 3 mg diluted in 50 mL of 0.9% sodium chloride by intravenous infusion pump at 4.1 mL/hour every 12 hours for 7 days after surgery, as part of the postoperative no-stoma management strategy.
Clear Liquid Diet
Other interventionParticipants in the experimental arm will receive a clear liquid diet after recovery of bowel gas passage, as part of the 7-day postoperative no-stoma management strategy. Parenteral nutrition may be provided according to clinical needs.
Prophylactic Diverting Stoma
Procedure/SurgeryParticipants in the control arm will undergo prophylactic diverting stoma creation during ultra-low anterior resection and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.
Grade C Anastomotic Leakage Within 1 Month After Surgery
Proportion of participants who develop grade C anastomotic leakage within 1 month after surgery. Grade C anastomotic leakage is defined as anastomotic leakage requiring reoperation.
Postoperative Complication Severity Within 1 Month After Surgery
Postoperative complications will be assessed within 1 month after surgery using the Clavien-Dindo classification. The highest complication grade for each participant will be recorded, with higher grades indicating more severe postoperative complications.
Low Anterior Resection Syndrome Score Within 1 Month After Surgery
Bowel dysfunction after low anterior resection will be assessed using the Low Anterior Resection Syndrome score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 42, with higher scores indicating worse bowel dysfunction.
Quality of Recovery Score Within 1 Month After Surgery
Quality of postoperative recovery will be assessed using the Quality of Recovery-15 score at 7 days, 14 days, and 1 month after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
Low Anterior Resection Syndrome Score During Long-term Follow-up
Bowel dysfunction after low anterior resection will be assessed using the Low Anterior Resection Syndrome score at 3 months, 6 months, 1 year, and 3 years after surgery. The total score ranges from 0 to 42, with higher scores indicating worse bowel dysfunction.
Quality of Recovery Score During Long-term Follow-up
Quality of postoperative recovery and patient-reported health status will be assessed using the Quality of Recovery-15 score at 3 months, 6 months, 1 year, and 3 years after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.
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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
