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

NCT04304183 | Unknown

• 1 other identifier: 20190410
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Defecation Function; Quality of Life

Keywords

Slow transit constipation; Defecation function; Quality of life

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (1)

• Number of Participants with complications

  from the pre-operation to the five years following surgery

Study Arms (1)

slow transit constipation

patients diagnosed with slow transit constipation had undergone surgery.

Procedure: total colectomy, ileorectal anastomosis

Interventions

total colectomy, ileorectal anastomosis PROCEDURE

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

slow transit constipation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• The clinical manifestations all met the Roman IV standard for the diagnosis of functional constipation.
• Patients with severe constipation symptoms were unable to defecate naturally and need laxatives to assist defecation or still unable to defecate.
• Colonic transport tests showed that the opaque X-ray markers remained more than 20% after 72 hours.
• All conservative treatment for more than 1 year failed.
• Patients had a strong desire for surgery, and no other contraindications to surgery.

You may not qualify if:

• Megacolon was detected with barium enema examination.
• Colonoscopy suggested the presence of intestinal organic lesions or a history of colorectal cancer treatment.
• Gastric and small intestinal transport dysfunction.
• There are depression, anxiety and other mental symptoms.
• Constipation type irritable bowel syndrome.
• History of inflammatory bowel disease.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Weidong Tong

Yuzhong, Chongqing Municipality, 400042, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25887580 BACKGROUND

• 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.

  PMID: 30948148 RESULT

Study Officials

• Weidong Tong, MD

  Army Military Medical University

  STUDY CHAIR

Central Study Contacts

Yue Tian, MD

CONTACT

18523159554; ty11860602@163.com

Weidong Tong, MD

CONTACT

02368757955; vdtong@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: March 11, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CN (1)