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

What Was Tested

This registered not phased trial tested Somatostatin.

These patients have a higher risk of leakage where the bowel is joined together after surgery.

It had two arms (groups): Somatostatin Plus Clear Liquid Diet Without Diverting Stoma (experimental) and Prophylactic Diverting Stoma (active comparator).

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.

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.

The registry classes the interventions as drug, other and procedure.

More on the Plan

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.

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.

Who Took Part

Enrollment: 72 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 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.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

The Somatostatin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2025-11-17 with completion listed for 2027-07-31.

It ran at 3 sites in China (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Grade C Anastomotic Leakage Within 1 Month After Surgery (time frame: Within 1 month after surgery).

It also tracked 3 secondary outcomes, for example Postoperative Complication Severity Within 1 Month After Surgery, Low Anterior Resection Syndrome Score Within 1 Month After Surgery and Quality of Recovery Score Within 1 Month After Surgery.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Somatostatin in 72 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.