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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00676000
• Collaborator: (none)
• Enrollment: 350
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Dyspareunia; Surgical Mesh	Procedure: Interrupted vaginal closure; Procedure: Continuous vaginal closure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh
• Study Start Date: Apr 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Interrupted vaginal closure	Procedure: Interrupted vaginal closure; Horizontal mattress closure of vaginal mucosa over mesh
Active Comparator: 2 Continuous vaginal closure	Procedure: Continuous vaginal closure; Running closure of vaginal mucosa over mesh

Outcome Measures

Primary Outcome Measures

1. Mesh exposure [One year]

Secondary Outcome Measures

1. Pain [One year]

2. Dyspareunia [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Danielle Patterson, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00676000
• Other Study ID Numbers: 2007p002015
• First Posted: May 12, 2008
• Last Update Posted: Mar 19, 2009
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Dyspareunia

Study Results

No Results Posted as of Mar 19, 2009