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

A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection

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

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Anastomotic Leakage
• Intervention / Treatment: Drug: Somatostatin; Other: Clear Liquid Diet; Procedure: Prophylactic Diverting Stoma

Detailed Description

This is a multicenter, open-label, randomized clinical trial evaluating a postoperative no-stoma management strategy in adults with low or mid rectal cancer undergoing ultra-low anterior resection. Patients undergoing ultra-low colorectal or coloanal anastomosis are at increased risk of anastomotic leakage. A prophylactic diverting stoma is commonly used to reduce the clinical consequences of leakage, but stoma creation may also lead to stoma-related complications, delayed stoma closure, additional surgery, and impaired quality of life.

The study evaluates whether a 7-day postoperative regimen of somatostatin plus a clear liquid diet can serve as an alternative strategy to reduce intestinal contents passing through the anastomosis during the early postoperative period. Somatostatin is used to reduce gastrointestinal secretions, and a clear liquid diet is used to limit solid residue in the digestive tract. The investigational strategy is compared with prophylactic diverting stoma, which is commonly used in patients considered to be at high risk of leakage after low rectal surgery.

Eligible participants will be randomly assigned in a 1:1 ratio to one of two treatment strategies after ultra-low anterior resection. Participants in the experimental group will not undergo prophylactic stoma creation and will receive somatostatin plus a clear liquid diet for 7 days after surgery. Participants in the control group will undergo prophylactic diverting stoma and receive standard postoperative care. Both groups will receive routine perioperative management according to clinical practice at the participating centers.

The primary clinical focus is severe anastomotic leakage within 1 month after surgery, defined as leakage requiring reoperation. The study will also assess postoperative complications, bowel function, quality of recovery, quality of life, and longer-term functional outcomes during follow-up. Participants will be followed for up to 3 years after surgery.

This trial is intended to determine whether somatostatin plus a clear liquid diet without prophylactic stoma can provide similar protection against severe anastomotic leakage compared with prophylactic diverting stoma, while reducing the need for stoma creation and its related burden.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antian Lu; Phone Number: +8613208585786; Email: lat0061@163.com
• Study Contact Backup: Name: Senyan Lai; Phone Number: +86 8366 3000 67933; Email: laisenyan@163.com

Study Locations

• China
  • Hubei
    • Ezhou, Hubei, China
      • Recruiting
      • Ezhou Central Hospital
      • Contact: Antian Lu; Phone Number: +8613208585786; Email: lat0061@163.com
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Antian Lu; Phone Number: +8613208585786; Email: lat0061@163.com
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Wuhan No. 6 Hospital
      • Contact: Antian Lu; Phone Number: +8613208585786; Email: lat0061@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Somatostatin Plus Clear Liquid Diet Without Diverting Stoma; 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; 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.; Other: Clear Liquid Diet; 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.
Active Comparator: Prophylactic Diverting Stoma; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 1 month after surgery
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.	7 days, 14 days, and 1 month after surgery
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.	7 days, 14 days, and 1 month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months, 6 months, 1 year, and 3 years after surgery
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.	3 months, 6 months, 1 year, and 3 years after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Shanxi Bethune Hospital; Ezhou Central Hospital; Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University; Taihe Hospital affiliated to Hubei University of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: May 16, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Rectal cancer; Anastomotic leakage; Bowel function; Somatostatin; Ultra-low anterior resection; Severe anastomotic leakage; Diverting stoma; Prophylactic stoma; Clear liquid diet
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Pathological Conditions, Signs and Symptoms; Rectal Neoplasms; Anastomotic Leak; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Pancreatic Hormones; Pituitary Hormone Release Inhibiting Hormones; Somatostatin
• Other Study ID Numbers: TJ-IRB202601038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared because the study involves clinical surgical data and long-term follow-up information from patients with rectal cancer. Data will be stored in a de-identified form for study analysis, but external sharing of individual participant data is not planned under the current ethics approval and informed consent process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No