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UnknownNCT04304183

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

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Third Military Medical University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREtotal colectomy, ileorectal anastomosisall patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.

Timeline

Start date
2019-01-01
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2020-03-11
Last updated
2023-11-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04304183. Inclusion in this directory is not an endorsement.