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

Not Applicable

Withdrawn

• Conditions: Pain; Dyspareunia; Surgical Mesh
• Interventions: Procedure: Interrupted vaginal closure; Procedure: Continuous vaginal closure

• Registration Number: NCT00676000
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-17
• Last Update Posted: 2009-03-19
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

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

Exclusion Criteria

• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Interrupted vaginal closure	Interrupted vaginal closure
2	Continuous vaginal closure	Continuous vaginal closure

Primary Outcome Measures

Name	Time	Method
Mesh exposure	One year

Secondary Outcome Measures

Name	Time	Method
Pain	One year
Dyspareunia	One year