STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05352074
Study type	Interventional
Source	Third Military Medical University
Contact	Yue Tian, MD
Phone	18523159554
Email	ty11860602@163.com
Status	Recruiting
Phase	N/A
Start date	March 27, 2022
Completion date	December 31, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.