Randomized Trial of Interrupted Versus Continuous Vaginal... | NCT00676000

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

NCT00676000

Sponsor

Brigham and Women's Hospital

Status

Withdrawn

Last Update Posted

Mar 19, 2009Estimated

Enrollment

350Estimated

Phase

Not Applicable

Conditions

Pain
Dyspareunia
Surgical Mesh

Interventions

Interrupted vaginal closure
Continuous vaginal closure

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to decrease in Avaulta mesh kit usage & inability to recruit study subjects.

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Not provided

First Submitted Date

May 8, 2008

First Submission Date that Met QC Criteria

May 8, 2008

First Posted Date

May 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2009

Last Update Posted Date

Mar 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Interrupted vaginal closure	Procedure: Interrupted vaginal closure
2	Active Comparator	Continuous vaginal closure	Procedure: Continuous vaginal closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interrupted vaginal closure	Procedure	Horizontal mattress closure of vaginal mucosa over mesh	1

Measure	Description	Time Frame
Mesh exposure		One year

Measure	Description	Time Frame
Pain		One year
Dyspareunia		One year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

Exclusion Criteria:

Pregnant

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Danielle Patterson, MD	Brigham and Women's Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D004414	Dyspareunia

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005831	Genital Diseases, Female

Browse Leaves

Not provided

Browse Branches

Not provided