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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00676000
• Other study ID #: 2007p002015
• Status: Withdrawn
• Phase: N/A
• First received: May 8, 2008
• Last updated: March 17, 2009
• Start date: April 2008

Study information

• Verified date: March 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 350
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspareunia
• Pain
• Surgical Mesh

Intervention

Procedure:
• Interrupted vaginal closure
Horizontal mattress closure of vaginal mucosa over mesh
• Continuous vaginal closure
Running closure of vaginal mucosa over mesh

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mesh exposure		One year	No
Secondary	Pain		One year	No
Secondary	Dyspareunia		One year	No