Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh - Full Text View

Sponsored by:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00676000

Purpose

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	Intervention
Pain Dyspareunia Surgical Mesh	Procedure: Interrupted vaginal closure Procedure: Continuous vaginal closure

MedlinePlus related topics: Female Sexual Dysfunction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Mesh exposure [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain [ Time Frame: One year ] [ Designated as safety issue: No ]
Dyspareunia [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	April 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Interrupted vaginal closure	Procedure: Interrupted vaginal closure Horizontal mattress closure of vaginal mucosa over mesh
2: Active Comparator Continuous vaginal closure	Procedure: Continuous vaginal closure Running closure of vaginal mucosa over mesh

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

Exclusion Criteria:

Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676000

Contacts

Contact: Danielle Patterson, MD

617-732-4838

dpatterson1@partners.org

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Danielle Patterson, MD 617-732-4838 dpatterson1@partners.org
Principal Investigator: Danielle Patterson, MD

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Danielle Patterson, MD

Brigham and Women's Hospital

More Information

Responsible Party:	Brigham and Women's Hospital ( Danielle Patterson, MD )
Study ID Numbers:	2007p002015
Study First Received:	May 8, 2008
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00676000
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Genital Diseases, Female
Sexual Dysfunction, Physiological
Mental Disorders

Pain
Genital Diseases, Male
Dyspareunia

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009