- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304183
Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yue Tian, MD
- Phone Number: 02368757955 18523159554
- Email: ty11860602@163.com
Study Contact Backup
- Name: Weidong Tong, MD
- Phone Number: 02368757955 02368757955
- Email: vdtong@163.com
Study Locations
-
-
Chongqing
-
Yuzhong, Chongqing, China, 400042
- Recruiting
- Weidong Tong
-
Contact:
- Weidong Tong, MD
- Phone Number: 86-23-68757956
- Email: vdtong@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
slow transit constipation
patients diagnosed with slow transit constipation had undergone surgery.
|
all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of bowel movements
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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
Time Frame: from the pre-operation to the five years following surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with complications
Time Frame: from the pre-operation to the five years following surgery
|
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
|
Collaborators and Investigators
Investigators
- Study Chair: Weidong Tong, MD, Army Military Medical University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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