Somatostatin with a clear liquid diet vs a diverting stoma after low rectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial compares two postoperative strategies in adults with stage I–III rectal cancer undergoing ultra-low anterior resection. One group receives a 7-day course of somatostatin and a clear liquid diet to limit intestinal contents and secretions, aiming to reduce severe anastomotic leakage. The control group receives a prophylactic diverting stoma plus standard postoperative care. Primary interest is whether the somatostatin-plus-diet approach provides similar protection against severe leakage within the first month after surgery. Secondary outcomes include bowel function, recovery metrics, and quality of life during follow-up. Eligible participants are adults 18–75 with risk factors for leakage undergoing low or mid rectal resection at participating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 18 to 75 years
2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center
3. 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
4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge
5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team
6. American Society of Anesthesiologists physical status classification is grade 3 or lower
7. Body mass index is less than 30 kg/m²
8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent

Exclusion Criteria:

1. Has another colorectal malignant tumor at the same time
2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge
3. Has metastatic disease before surgery
4. Is pregnant
5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial
6. Requires emergency surgery
7. Has inflammatory bowel disease
8. Is allergic to somatostatin or is unable to tolerate somatostatin
9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required
10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery
11. Has any other condition that makes it impossible to follow the study protocol

Where it's running

• Ezhou Central Hospital
  Ezhou, Hubei, China Recruiting
• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Wuhan No. 6 Hospital
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Antian Lu
• Email: lat0061@163.com
• Phone: +8613208585786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.