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

NCT ID: NCT04304183

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Defecation Function Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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slow transit constipation

patients diagnosed with slow transit constipation had undergone surgery.

total colectomy, ileorectal anastomosis

Intervention Type PROCEDURE

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

Interventions

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total colectomy, ileorectal anastomosis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weidong Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weidong Tong, MD

Role: STUDY_CHAIR

Army Military Medical University

Locations

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Weidong Tong

Yuzhong, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yue Tian, MD

Role: CONTACT

[email protected]
18523159554 ext. 02368757955

Weidong Tong, MD

Role: CONTACT

[email protected]
02368757955 ext. 02368757955

Facility Contacts

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Weidong Tong, MD

Role: primary

[email protected]
86-23-68757956

References

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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.

Reference Type BACKGROUND
PMID: 25887580 (View on PubMed)

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.

Reference Type RESULT
PMID: 30948148 (View on PubMed)

Other Identifiers

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20190410

Identifier Type: -

Identifier Source: org_study_id