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

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

• Status: Recruiting
• Conditions: Quality of Life; Defecation Function
• Intervention / Treatment: Procedure: total colectomy, ileorectal anastomosis

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

• Study Contact: Name: Yue Tian, MD; Phone Number: 02368757955 18523159554; Email: ty11860602@163.com
• Study Contact Backup: Name: Weidong Tong, MD; Phone Number: 02368757955 02368757955; Email: vdtong@163.com

Study Locations

• China
  • Chongqing
    • Yuzhong, Chongqing, China, 400042
      • Recruiting
      • Weidong Tong
      • Contact: Weidong Tong, MD; Phone Number: 86-23-68757956; Email: vdtong@163.com

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
slow transit constipation; patients diagnosed with slow transit constipation had undergone surgery.	Procedure: total colectomy, ileorectal anastomosis; 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	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	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	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	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	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	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	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	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	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	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	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	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

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

Publications and helpful links

General Publications

• Wei D, Cai J, Yang Y, Zhao T, Zhang H, Zhang C, Zhang Y, Zhang J, Cai F. A prospective comparison of short term results and functional recovery after laparoscopic subtotal colectomy and antiperistaltic cecorectal anastomosis with short colonic reservoir vs. long colonic reservoir. BMC Gastroenterol. 2015 Mar 18;15:30. doi: 10.1186/s12876-015-0257-7.
• Macha MR. The feasibility of laparoscopic subtotal colectomy with cecorectal anastomosis in community practice for slow transit constipation. Am J Surg. 2019 May;217(5):974-978. doi: 10.1016/j.amjsurg.2019.03.018. Epub 2019 Mar 26.

Study record dates

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

• Keywords: Quality of life; Slow transit constipation; Defecation function
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• 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