Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321867
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2006-05-03
Brief Title:
Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Sponsor:
Women and Infants Hospital of Rhode Island
Organization:
Women and Infants Hospital of Rhode Island
Study Overview
Official Title:
Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
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?:
None