Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation

Recruiting

• Conditions: Quality of Life; Defecation Function
• Interventions: Procedure: total colectomy, ileorectal anastomosis

• Registration Number: NCT04304183
• Lead Sponsor: Third Military Medical University

Brief Summary

Although surgical options for slow transit constipation (STC) have been proven to be a definite treatment, improvements in the associated defecation function and quality of life are rarely studied. This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life in 5-year regular follow-up.

Detailed 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, 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\[6\], including ileorectal anastomosis (IRA), cecorectal anastomosis(CRA), colonic exclusion, antegrade enemas (the Malone procedure), modified Duhamel surgery, and permanent ileostomy. Currently, the main surgical procedures for STC are IRA and CRA, which have been widely confirmed to increase bowel-movement frequency in a huge number of patients. However, the reported outcomes of colectomy are controversial and conflicting.In these studies, lack of prospectively defined follow-up intervals is a general problem. Moreover, long-term outcomes of surgery for STC are rarely reported. Furthermore, negatively persistent symptoms including abdominal pain, bloating, intractable diarrhea, malnutrition, constipation recurrence, fecal incontinence, and intestinal obstruction are not uncommon following surgery, adversely affecting defecation function and quality of life following these procedures.

This study aims to investigate the effectiveness of total or subtotal colectomy, with respect to short- and long-term defecation function and overall quality of life during 5-year regular follow-up.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2020-03-07
• Study First Posted: 2020-03-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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. There are depression, anxiety and other mental symptoms.
5. Constipation type irritable bowel syndrome.
6. History of inflammatory bowel disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
slow transit constipation	total colectomy, ileorectal anastomosis	patients diagnosed with slow transit constipation had undergone surgery.

Primary Outcome Measures

Name	Time	Method
The scales of Wexner Incontinence	from the pre-operation to the five years following surgery	the scales of Wexner Incontinence will be recorded in terms of scores.
The incidence of abdominal pain	from the pre-operation to the five years following surgery	the incidence of abdominal pain will be recorded in terms of percent.
The incidence of straining	from the pre-operation to the five years following surgery	the incidence of straining will be recorded in terms of percent.
The incidence of laxative	from the pre-operation to the five years following surgery	the incidence of laxative will be recorded in terms of percent.
The scales of Gastrointestinal Quality of Life Index	from the pre-operation to the five years following surgery	the scales of Gastrointestinal Quality of Life Index will be recorded in terms of scores.
The number of bowel movements	from the pre-operation to the five years following surgery	the number of bowel movements will be recorded in terms of times per week.
The scales of Wexner Constipation	from the pre-operation to the five years following surgery	the scales of Wexner Constipation will be recorded in terms of scores.
The incidence of bloating	from the pre-operation to the five years following surgery	the incidence of bloating will be recorded in terms of percent.
The incidence of diarrhea	from the pre-operation to the five years following surgery	the incidence of diarrhea will be recorded in terms of percent.
The incidence of enema use	from the pre-operation to the five years following surgery	the incidence of enema use will be recorded in terms of percent.
The short-form(SF)-36 survey	from the pre-operation to the five years following surgery	There are eight spheres in the SF-36 survey, including physical function, role physical, role emotional, physical pain, vitality, mental health, social function and general health. Results of each sphere will be recorded in terms of scores.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with complications	from the pre-operation to the five years following surgery	Postoperative complications includes short-term and long-term complications, such as ileus, anastomotic leak, small intestinal obstruction, constipation recurrence and so on. Number of Participants with complications will be recorded.

Trial Locations

Locations (1)

Weidong Tong; 🇨🇳 Yuzhong, Chongqing, China