Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection

NCT07605611 | Recruiting DMC

• 1 other identifier: TJ-IRB202601038
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rectal Cancer; Anastomotic Leakage

Keywords

Rectal cancer; Ultra-low anterior resection; Anastomotic leakage; Severe anastomotic leakage; Diverting stoma; Prophylactic stoma; Somatostatin; Clear liquid diet; Bowel function; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 month after surgery

Secondary Outcomes (3)

• Postoperative Complication Severity Within 1 Month After Surgery

  Within 1 month after surgery

• Low Anterior Resection Syndrome Score Within 1 Month After Surgery

  7 days, 14 days, and 1 month after surgery

• Quality of Recovery Score Within 1 Month After Surgery

  7 days, 14 days, and 1 month after surgery

Other Outcomes (2)

• Low Anterior Resection Syndrome Score During Long-term Follow-up

  3 months, 6 months, 1 year, and 3 years after surgery

• Quality of Recovery Score During Long-term Follow-up

  3 months, 6 months, 1 year, and 3 years after surgery

Study Arms (2)

Somatostatin Plus Clear Liquid Diet Without Diverting Stoma

EXPERIMENTAL

Participants in this arm will undergo ultra-low anterior resection without prophylactic diverting stoma. After surgery, they will receive somatostatin plus a clear liquid diet for 7 days, along with routine postoperative care.

Drug: Somatostatin; Other: Clear Liquid Diet

Prophylactic Diverting Stoma

ACTIVE COMPARATOR

Participants in this arm will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.

Procedure: Prophylactic Diverting Stoma

Interventions

Somatostatin DRUG

Participants 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.

Somatostatin Plus Clear Liquid Diet Without Diverting Stoma

Clear Liquid Diet OTHER

Participants 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.

Somatostatin Plus Clear Liquid Diet Without Diverting Stoma

Prophylactic Diverting Stoma PROCEDURE

Participants 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.

Prophylactic Diverting Stoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead
• 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

Study Sites (3)

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

Related Publications (7)

• Kang CY, Halabi WJ, Chaudhry OO, Nguyen V, Pigazzi A, Carmichael JC, Mills S, Stamos MJ. Risk factors for anastomotic leakage after anterior resection for rectal cancer. JAMA Surg. 2013 Jan;148(1):65-71. doi: 10.1001/2013.jamasurg.2.

  PMID: 22986932 BACKGROUND

• Stevens P, Foulkes RE, Hartford-Beynon JS, Delicata RJ. Systematic review and meta-analysis of the role of somatostatin and its analogues in the treatment of enterocutaneous fistula. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):912-22. doi: 10.1097/MEG.0b013e32834a345d.

  PMID: 21814141 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.

  PMID: 22504191 BACKGROUND

• Kulu Y, Ulrich A, Bruckner T, Contin P, Welsch T, Rahbari NN, Buchler MW, Weitz J; International Study Group of Rectal Cancer. Validation of the International Study Group of Rectal Cancer definition and severity grading of anastomotic leakage. Surgery. 2013 Jun;153(6):753-61. doi: 10.1016/j.surg.2013.02.007. Epub 2013 Apr 25.

  PMID: 23623834 BACKGROUND

• Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.

  PMID: 20004450 BACKGROUND

• Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.

  PMID: 17667498 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Anastomotic Leak

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Antian Lu

CONTACT

+8613208585786; lat0061@163.com

Senyan Lai

CONTACT

+86 8366 3000 67933; laisenyan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Masking is not feasible because the assigned treatment strategies are clinically apparent: participants either undergo prophylactic diverting stoma creation or do not undergo stoma creation and receive postoperative somatostatin plus a clear liquid diet.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Associate Chief Physician, Department of Gastrointestinal Surgery

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo ultra-low anterior resection without prophylactic stoma and will receive somatostatin plus a clear liquid diet for 7 days after surgery. The control group will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 26, 2026
• Study Start: November 17, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)