Obstructive Defecation SyndromeNCT03060330
Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome
A study testing Modified Laparoscopic Ventral Mesh Rectopexy and Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection in people with Obstructive Defecation Syndrome and Chronic Constipation, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obstructive Defecation Syndrome, Chronic Constipation, Rectal Prolapse
- What is being tested?
- Modified Laparoscopic Ventral Mesh Rectopexy and Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2017to Apr 2026
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by obstructed defecation with a minimum ODS score of 10
- External rectal prolapse or high-grade internal rectal prolapse
- Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
- Have experienced ODS symptoms for at least 12 months prior to enrollment
- Failure of at least 6 months of medical therapy
- American Society of Anesthesiologists (ASA) score of no more than 3
Who cannot join
- Slow transit constipation
- Anismus resistant to conventional treatment
- No demonstrable pelvic anatomical problem
- Previous rectal or anal surgery
- Recto-vaginal fistula
- Pregnancy
Show all 14Show fewer
- Previous pelvic radiotherapy
- Severe proctitis or significant rectal fibrosis
- Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
- Perineal infection
- High-grade endometriosis
- Morbid obesity
- A hostile abdomen
- Psychological instability
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Tao Fu, MD, 86-13720120190, futao1975@tom.com
About this study
Official title: Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.
- Being tested
- Modified Laparoscopic Ventral Mesh Rectopexy, Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Laparoscopic Ventral Mesh RectopexyProcedure or surgery
This group will undergo modified laparoscopic ventral mesh rectopexy alone
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal ResectionProcedure or surgery
This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection
| Study group | Role | What they receive |
|---|---|---|
| LVMR | Experimental | Modified Laparoscopic Ventral Mesh Rectopexy Receives: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy |
| LVMR with STARR | Experimental | Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection Receives: Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the ODS score (ODS-S)
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
Measured: Baseline and 12 months after surgery
Secondary outcomes (7)
Postoperative complications
Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.
Measured: 0 to 12 months after surgery
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)
This is a measure of efficacy.
Measured: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Health-Related Quality of Life
SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.
Measured: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)
This is a measure of efficacy.
Measured: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
This is a measure of efficacy.
Measured: Baseline, 1, 3, 6, and 12 months after surgery
Radiological outcome as assessed by defecography
This is a measure of efficacy.
Measured: Baseline and 12 months after surgery
Changes in the ODS score (ODS-S)
This is a measure of efficacy.
Measured: Baseline, 1, 3, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start26 Apr 2017
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Defecation SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Fu, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060330
- Sponsor's protocol ID
- LVMRSTARRODS2017
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructed Defecation Caused by Rectal Prolapse and Rectocele: Laparoscopic Ventral Rectopexy Alone Versus Laparoscopic Ventral Rectopexy Combined With Stapled Trans-anal Rectal Resection
- ClinicalTrials.gov ID
- NCT03060330
- Acronym / sponsor ID
- LVMRSTARRODS2017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Feb 2017 (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.
Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LVMR | Experimental | Procedure: Modified Laparoscopic Ventral Mesh RectopexyModified Laparoscopic Ventral Mesh Rectopexy |
| LVMR with STARR | Experimental | Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal ResectionModified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients affected by obstructed defecation with a minimum ODS score of 10
- External rectal prolapse or high-grade internal rectal prolapse
- Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
- Have experienced ODS symptoms for at least 12 months prior to enrollment
- Failure of at least 6 months of medical therapy
Key exclusion criteria (14 listed)
- Slow transit constipation
- Anismus resistant to conventional treatment
- No demonstrable pelvic anatomical problem
- Previous rectal or anal surgery
- Recto-vaginal fistula
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 |
|---|---|---|
| Modified Laparoscopic Ventral Mesh RectopexyThis group will undergo modified laparoscopic ventral mesh rectopexy alone | Procedure or surgery | LVMR |
| Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal ResectionThis group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection | Procedure or surgery | LVMR with STARR |
Primary outcome
Changes in the ODS score (ODS-S)
Time frame: Baseline and 12 months after surgery
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
7 secondary outcomes
Postoperative complications
Time frame: 0 to 12 months after surgery
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Health-Related Quality of Life
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Radiological outcome as assessed by defecography
Time frame: Baseline and 12 months after surgery
Changes in the ODS score (ODS-S)
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Laparoscopic Ventral Mesh Rectopexy and Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection in people with Obstructive Defecation Syndrome and Chronic Constipation, run by Renmin Hospital of Wuhan 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 6 inclusion and 14 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 15 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Fu, MD (86-13720120190, futao1975@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the ODS score (ODS-S) (time frame: Baseline and 12 months after surgery). 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 15 Mar 2022.