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

November 23, 2023 updated by: Weidong Tong, Third Military Medical University
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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Weidong Tong, MD
  • Phone Number: 02368757955 02368757955
  • Email: vdtong@163.com

Study Locations

    • Chongqing
      • Yuzhong, Chongqing, China, 400042
        • Recruiting
        • Weidong Tong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients diagnosed with STC in the investigator's department were preoperatively included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
slow transit constipation
patients diagnosed with slow transit constipation had undergone surgery.
all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of bowel movements
Time Frame: from the pre-operation to the five years following surgery
the number of bowel movements will be recorded in terms of times per week.
from the pre-operation to the five years following surgery
The scales of Wexner Constipation
Time Frame: from the pre-operation to the five years following surgery
the scales of Wexner Constipation will be recorded in terms of scores.
from the pre-operation to the five years following surgery
The scales of Wexner Incontinence
Time Frame: from the pre-operation to the five years following surgery
the scales of Wexner Incontinence will be recorded in terms of scores.
from the pre-operation to the five years following surgery
The incidence of abdominal pain
Time Frame: from the pre-operation to the five years following surgery
the incidence of abdominal pain will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The incidence of bloating
Time Frame: from the pre-operation to the five years following surgery
the incidence of bloating will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The incidence of diarrhea
Time Frame: from the pre-operation to the five years following surgery
the incidence of diarrhea will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The incidence of straining
Time Frame: from the pre-operation to the five years following surgery
the incidence of straining will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The incidence of laxative
Time Frame: from the pre-operation to the five years following surgery
the incidence of laxative will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The incidence of enema use
Time Frame: from the pre-operation to the five years following surgery
the incidence of enema use will be recorded in terms of percent.
from the pre-operation to the five years following surgery
The scales of Gastrointestinal Quality of Life Index
Time Frame: 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.
from the pre-operation to the five years following surgery
The short-form(SF)-36 survey
Time Frame: 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.
from the pre-operation to the five years following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with complications
Time Frame: 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.
from the pre-operation to the five years following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Weidong Tong, MD, Army Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

March 7, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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