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

Mass General Brigham

Status: Withdrawn

Conditions: Dyspareunia; Surgical Mesh; Pain

Treatments: Procedure: Continuous vaginal closure; Procedure: Interrupted vaginal closure

Study type: Interventional

Funder types: Other

Identifiers

NCT00676000

2007p002015

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

1

Active Comparator group

Description:

Interrupted vaginal closure

Treatment:

Procedure: Interrupted vaginal closure

2

Active Comparator group

Description:

Continuous vaginal closure

Treatment:

Procedure: Continuous vaginal closure