Defecation FunctionNCT04304183
Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
An observational study of Defecation Function and Quality of Life, run by Third Military Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Defecation Function, Quality of Life
- What is being tested?
- total colectomy, ileorectal anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with STC in the investigator's department were preoperatively included.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weidong Tong
Yuzhong, Chongqing Municipality, 400042
Weidong Tong, MD, 86-23-68757956, vdtong@163.com
About this study
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.
Read the 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
- Defecation Function, Quality of Life
- Being tested
- total colectomy, ileorectal anastomosis
- Keywords
- Slow transit constipation, Defecation function, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total colectomy, ileorectal anastomosisProcedure or surgery
all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.
| Study group | Role | What they receive |
|---|---|---|
| slow transit constipation | patients diagnosed with slow transit constipation had undergone surgery. Receives: Procedure: total colectomy, ileorectal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of bowel movements
the number of bowel movements will be recorded in terms of times per week.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from the pre-operation to the five years following surgery
Secondary outcomes (1)
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.
Measured: from the pre-operation to the five years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Defecation FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Tong, Third Military Medical University
- Investigators
- Weidong Tong, MD, Study chair, Army Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304183
- Sponsor's protocol ID
- 20190410
- Status last verified
- Nov 2023
- First submitted
- 6 May 2019
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 25887580Macha 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.
PubMed 30948148
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defecation Function and Quality of Life in the Patients Treated With Surgery for Slow Transit Constipation
- ClinicalTrials.gov ID
- NCT04304183
- Acronym / sponsor ID
- 20190410
- Conditions
- Defecation Function, Quality of Life
- Keywords
- Slow transit constipation, Defecation function, Quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| slow transit constipation | – | Procedure: total colectomy, ileorectal anastomosispatients diagnosed with slow transit constipation had undergone surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with STC in the investigator's department were preoperatively included.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total colectomy, ileorectal anastomosisall patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients. | Procedure or surgery | slow transit constipation |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Number of Participants with complications
Time frame: from the pre-operation to the five years following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Background: PubMed 25887580Wei 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.
- Results publication: PubMed 30948148Macha 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.
- Individual participant dataSharing planned: Undecided
Related trials for Defecation Function
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
Recruiting
The Food Network Effect
Post Operative Patients
Enrolling by invitation
Biofeedback for Women With Dyssynergic Defecation (DD)
Dyssenergic Defecation, Straining, Hard Stools, Incomplete Evacuation
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Recruiting
Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Tong, MD study chair
Army Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Defecation Function and Quality of Life, run by Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Tian, MD (18523159554 ext. 02368757955, ty11860602@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of bowel movements (time frame: from the pre-operation to the five years following surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04304183, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.