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Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

Primary Purpose

Pain, Dyspareunia, Surgical Mesh

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interrupted vaginal closure
Continuous vaginal closure
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

Exclusion Criteria:

  • Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Interrupted vaginal closure

    Continuous vaginal closure

    Outcomes

    Primary Outcome Measures

    Mesh exposure

    Secondary Outcome Measures

    Pain
    Dyspareunia

    Full Information

    First Posted
    May 8, 2008
    Last Updated
    March 17, 2009
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00676000
    Brief Title
    Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
    Official Title
    Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to decrease in Avaulta mesh kit usage & inability to recruit study subjects.
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    December 2009 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Dyspareunia, Surgical Mesh

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Interrupted vaginal closure
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Continuous vaginal closure
    Intervention Type
    Procedure
    Intervention Name(s)
    Interrupted vaginal closure
    Intervention Description
    Horizontal mattress closure of vaginal mucosa over mesh
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous vaginal closure
    Intervention Description
    Running closure of vaginal mucosa over mesh
    Primary Outcome Measure Information:
    Title
    Mesh exposure
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    Pain
    Time Frame
    One year
    Title
    Dyspareunia
    Time Frame
    One year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Scheduled for surgery to correct anterior vaginal prolapse with mesh kit Exclusion Criteria: Pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danielle Patterson, MD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

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