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STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

Recruiting
18-80 years
All
Phase N/A

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Overview

Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation. Subtotal colectomy with caecorectal anastomosis is suggested to be a superior approach. However, the optimal surgical option for slow transit constipation (STC) is controversial.

Description

Constipation is an ever-growing problem and one of the most common gastrointestinal symptoms, affecting 10-15% of adults in the USA and 8.2% of the general population in China. Slow transit constipation(STC), representing 15~30% constipated patients, is characterized by a loss in the colonic motor activity. Factors such as increasing age, female sex, physical inactivity, endocrine,metabolism, neurological factors, drug use, and depression are associated with constipation. While most patients with constipation are mild and treated easily by a behavioral and medical way, a minority of patients suffering from long-term intractable symptoms and poor quality of life and showing no response to any medical interventions are ultimately recommended for surgery.Since the effectiveness of colectomy for constipation was first reported by Lane a century ago, surgical treatment for constipation has been greatly developed, including ileorectal anastomosis (IRA), cecorectal anastomosis(CRA), colonic exclusion, antegrade enemas (the Maloneprocedure), modified Duhamel surgery, and permanent ileostomy. Currently,the main surgical procedures for STC are total colectomy with ileorectal anastomosis (TC-IRA) and subtotal colectomy with caecorectal anastomosis(SC-CRA), which have been widely confirmed to increase bowel-movement frequency in a huge number of patients. However, TC-IRA is a traditional surgical option for slow transit constipation. SC-CRA is suggested to be a superior approach. However, the optimal surgical option for slow transit constipation (STC) is controversial.This study aims to compare TC-IRA versus SC-CRA for STC with respect to the short- and long-term defecation function and overall quality of life during 3-year regular follow-up.

Eligibility

Inclusion Criteria:

  1. The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
  2. Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
  3. Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
  4. All conservative treatment for more than 1 year failed.
  5. Patients had a strong desire for surgery, and no other contraindications to surgery.

Exclusion Criteria:

  1. Megacolon was detected with barium enema examination.
  2. Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
  3. Gastric and small intestinal transport dysfunction.
  4. rectal inertia.
  5. Moderate or severe than depression, anxiety and other mental symptoms.
  6. Constipation-predominant irritable bowel syndrome.
  7. History of inflammatory bowel disease.
  8. enterostomy, without anastomosis.
  9. Pregnant Or Lactating Women.

Study details
    Slow Transit Constipation
    Surgery

NCT05352074

Third Military Medical University

27 January 2024

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