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

NCT00676000 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2009-03-19

No results posted yet for this study

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.

Conditions

  • Pain
  • Dyspareunia
  • Surgical Mesh

Interventions

PROCEDURE

Interrupted vaginal closure

Horizontal mattress closure of vaginal mucosa over mesh

PROCEDURE

Continuous vaginal closure

Running closure of vaginal mucosa over mesh

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Danielle Patterson, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00676000 on ClinicalTrials.gov