Constipation by Outlet ObstructionNCT03487640
Surgical Treatment for ODS With Rectal Prolapse Surgical Treatment for Rectal Prolapse
An observational study of Constipation by Outlet Obstruction, run by Third Military Medical University at 1 site in China.
Trial summary
Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Constipation by Outlet Obstruction
- What is being tested?
- TARMR and LARSC
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2018to 31 Dec 2021
- 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: Meet for Rome IV criteria for constipation.
Who may be able to join
- Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI.
- Patients should accord with Rome IV criteria.
Who cannot join
- Severe heart or other organ disease.
- test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopica Hindgut Resection Plus Rectum Suspention Compare With Transanal Rectal Mucosa Resection for ODS With Rectal Prolapse
Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.
- Conditions
- Constipation by Outlet Obstruction
- Being tested
- TARMR, LARSC
- Keywords
- constipation, surgery
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARMRProcedure or surgery
Transanal resection of rectal mucosa for at least 5cm in length.
LARSCProcedure or surgery
We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically
| Study group | Role | What they receive |
|---|---|---|
| Transanal rectal mucosa resection | TARMR: Transanal resection of rectal mucosa for at least 5cm in length. Receives: Procedure: TARMR | |
| Laparoscopic rectal suspension and colectomy | LARSC: We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically Receives: Procedure: LARSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wexner constipation score
The Wexner constipation score should be filled out
Measured: 2019.1-2019.12
patients' satisfaction rate
The researcher will statistic the satisfaction rate of the patients
Measured: 2019.1-2019.12
Secondary outcomes (3)
short period complications
postoperative 30-day complications
Measured: 2018.1-2019.12
operative time
the total operative time
Measured: 2018.1-2019.12
quality of life
SF-36 form
Measured: 2019.1-2019.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start8 Jan 2018
- Primary completion8 Jan 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation by Outlet ObstructionStudies 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
- 16 participants (actual)
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
- Yong Yang, Dr., Study chair, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487640
- Sponsor's protocol ID
- LarTARP
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2018
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopica Hindgut Resection Plus Rectum Suspention Compare With Transanal Rectal Mucosa Resection for ODS With Rectal Prolapse
- ClinicalTrials.gov ID
- NCT03487640
- Acronym / sponsor ID
- LarTARP
- Conditions
- Constipation by Outlet Obstruction
- Keywords
- constipation, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Apr 2018 (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.
Chronic obstinate constipation is hard to deal with in clinic. Especially for obstructed defecation syndrome(ODS). Rectal prolapse is the most common type of ODS. Lots of surgical procedures have been suggested for it but with unsatisfactory results.To develop new surgical treatment and to provide higher quality proof for this intractable condition is of significance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal rectal mucosa resection | – | Procedure: TARMRTARMR: Transanal resection of rectal mucosa for at least 5cm in length. |
| Laparoscopic rectal suspension and colectomy | – | Procedure: LARSCLARSC: We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Meet for Rome IV criteria for constipation.
Key inclusion criteria (2 listed)
- Diagnosed with ODS by defecography, coloscopy, barium enema and dynamic MRI.
- Patients should accord with Rome IV criteria.
Key exclusion criteria (2 listed)
- Severe heart or other organ disease.
- test.
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 |
|---|---|---|
| TARMRTransanal resection of rectal mucosa for at least 5cm in length. | Procedure or surgery | Transanal rectal mucosa resection |
| LARSCWe are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically | Procedure or surgery | Laparoscopic rectal suspension and colectomy |
Primary outcome
Wexner constipation score
Time frame: 2019.1-2019.12
The Wexner constipation score should be filled out
patients' satisfaction rate
Time frame: 2019.1-2019.12
The researcher will statistic the satisfaction rate of the patients
3 secondary outcomes
short period complications
Time frame: 2018.1-2019.12
operative time
Time frame: 2018.1-2019.12
quality of life
Time frame: 2019.1-2019.12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Constipation by Outlet Obstruction
Recruiting
Defecation Patterns in Constipated Patients
Constipation by Outlet Obstruction
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.
Yong Yang, Dr. study chair
Daping Hospital and the Research Institute of Surgery of the Third 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 Constipation by Outlet Obstruction, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wexner constipation score (time frame: 2019.1-2019.12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2022.