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

NCT ID: NCT00676000

Last Updated: 2009-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Dyspareunia Surgical Mesh

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Interrupted vaginal closure

Group Type ACTIVE_COMPARATOR

Interrupted vaginal closure

Intervention Type PROCEDURE

Horizontal mattress closure of vaginal mucosa over mesh

2

Continuous vaginal closure

Group Type ACTIVE_COMPARATOR

Continuous vaginal closure

Intervention Type PROCEDURE

Running closure of vaginal mucosa over mesh

Interventions

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Interrupted vaginal closure

Horizontal mattress closure of vaginal mucosa over mesh

Intervention Type PROCEDURE

Continuous vaginal closure

Running closure of vaginal mucosa over mesh

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital

Principal Investigators

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Danielle Patterson, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Other Identifiers

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2007p002015

Identifier Type: -

Identifier Source: org_study_id

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