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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304183
• Other study ID #: 20190410
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Third Military Medical University
• Contact: Yue Tian, MD
• Phone: 18523159554
• Email: ty11860602[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Defecation Function
• Quality of Life

Intervention

Procedure:
• total colectomy, ileorectal anastomosis
all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.

Locations

Country	Name	City	State
China	Weidong Tong	Yuzhong	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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