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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04304183
Enrollment
100
Registered
2020-03-11
Start date
2019-01-01
Completion date
2025-12-31
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defecation Function, Quality of Life

Keywords

Slow transit constipation, Defecation function, Quality of life

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.

Interventions

PROCEDUREtotal colectomy, ileorectal anastomosis

all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.

Sponsors

Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The short-form(SF)-36 surveyfrom the pre-operation to the five years following surgeryThere 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.
The number of bowel movementsfrom the pre-operation to the five years following surgerythe number of bowel movements will be recorded in terms of times per week.
The scales of Wexner Constipationfrom the pre-operation to the five years following surgerythe scales of Wexner Constipation will be recorded in terms of scores.
The scales of Wexner Incontinencefrom the pre-operation to the five years following surgerythe scales of Wexner Incontinence will be recorded in terms of scores.
The incidence of abdominal painfrom the pre-operation to the five years following surgerythe incidence of abdominal pain will be recorded in terms of percent.
The incidence of bloatingfrom the pre-operation to the five years following surgerythe incidence of bloating will be recorded in terms of percent.
The incidence of diarrheafrom the pre-operation to the five years following surgerythe incidence of diarrhea will be recorded in terms of percent.
The incidence of strainingfrom the pre-operation to the five years following surgerythe incidence of straining will be recorded in terms of percent.
The incidence of laxativefrom the pre-operation to the five years following surgerythe incidence of laxative will be recorded in terms of percent.
The incidence of enema usefrom the pre-operation to the five years following surgerythe incidence of enema use will be recorded in terms of percent.
The scales of Gastrointestinal Quality of Life Indexfrom the pre-operation to the five years following surgerythe scales of Gastrointestinal Quality of Life Index will be recorded in terms of scores.

Secondary

MeasureTime frameDescription
Number of Participants with complicationsfrom the pre-operation to the five years following surgeryPostoperative 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.

Countries

China

Contacts

Primary ContactYue Tian, MD
ty11860602@163.com18523159554
Backup ContactWeidong Tong, MD
vdtong@163.com02368757955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026