Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection
Recruiting · NCT07605611 · Interventional (participants receive a specific treatment) · Lead sponsor: Tongji Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Has a mental illness or addictive disorder that would prevent participation in the clinical trial
- Requires emergency surgery
- Has inflammatory bowel disease
- Is allergic to somatostatin or is unable to tolerate somatostatin
- For participants assigned to the no-stoma group, the surgeon decides that a stoma is required
- Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery
- Has any other condition that makes it impossible to follow the study protocol
Where it is running
3 locations listed.
- Ezhou Central Hospital - Ezhou, Hubei, China
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China
- Wuhan No. 6 Hospital - Wuhan, Hubei, China