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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00676000
Enrollment
350
Registered
2008-05-12
Start date
2008-04-30
Completion date
Unknown
Last updated
2009-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspareunia, Pain, Surgical Mesh

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.

Interventions

PROCEDUREInterrupted vaginal closure

Horizontal mattress closure of vaginal mucosa over mesh

PROCEDUREContinuous vaginal closure

Running closure of vaginal mucosa over mesh

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Pregnant

Design outcomes

Primary

MeasureTime frame
Mesh exposureOne year

Secondary

MeasureTime frame
PainOne year
DyspareuniaOne year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026