PainNCT00676000
Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
A study testing Interrupted vaginal closure and Continuous vaginal closure in people with Pain and Dyspareunia, run by Brigham and Women's Hospital.
Trial summary
Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Dyspareunia, Surgical Mesh
- What is being tested?
- Interrupted vaginal closure and Continuous vaginal closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Dec 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for surgery to correct anterior vaginal prolapse with mesh kit
Who cannot join
- Pregnant
About this study
Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.
- Conditions
- Pain, Dyspareunia, Surgical Mesh
- Being tested
- Interrupted vaginal closure, Continuous vaginal closure
- Medical subject headings
- Pain, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted vaginal closureProcedure or surgery
Horizontal mattress closure of vaginal mucosa over mesh
Continuous vaginal closureProcedure or surgery
Running closure of vaginal mucosa over mesh
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Interrupted vaginal closure Receives: Procedure: Interrupted vaginal closure |
| 2 | Active comparator | Continuous vaginal closure Receives: Procedure: Continuous vaginal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesh exposure
Measured: One year
Secondary outcomes (2)
Pain
Measured: One year
Dyspareunia
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009 (estimated)
Why it stopped: Due to decrease in Avaulta mesh kit usage \& inability to recruit study subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Danielle Patterson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676000
- Sponsor's protocol ID
- 2007p002015
- Status last verified
- Mar 2009
- First submitted
- 8 May 2008
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
- ClinicalTrials.gov ID
- NCT00676000
- Acronym / sponsor ID
- 2007p002015
- Conditions
- Pain, Dyspareunia, Surgical Mesh
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to decrease in Avaulta mesh kit usage \& inability to recruit study subjects.
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 12 May 2008 (estimated)
- 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.
Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Interrupted vaginal closureInterrupted vaginal closure |
| 2 | Active comparator | Procedure: Continuous vaginal closureContinuous vaginal closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for surgery to correct anterior vaginal prolapse with mesh kit
Key exclusion criteria (1 listed)
- Pregnant
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 |
|---|---|---|
| Interrupted vaginal closureHorizontal mattress closure of vaginal mucosa over mesh | Procedure or surgery | 1 |
| Continuous vaginal closureRunning closure of vaginal mucosa over mesh | Procedure or surgery | 2 |
Primary outcome
Mesh exposure
Time frame: One year
2 secondary outcomes
Pain
Time frame: One year
Dyspareunia
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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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.
Danielle Patterson, MD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted vaginal closure and Continuous vaginal closure in people with Pain and Dyspareunia, run by Brigham and Women's Hospital.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Mesh exposure (time frame: One year). 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 Mar 2009.