Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00321867
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2006-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Study Overview
Official Title:
Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.
Detailed Description:
Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.
Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: