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

RecruitingNAAges 18 Years - 75 YearsAllTongji Hospital
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In plain words

What the trial is, and whether it could suit you

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 sev

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mยฒ 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
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What it tests

  • Somatostatin
  • Clear Liquid Diet
  • Prophylactic Diverting Stoma
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Where

3 sites
Ezhou Central Hospital
Ezhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuhan No. 6 Hospital
Wuhan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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