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Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging

Rectocele Clinical Trial

Official title:
Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?

Clinical Trial Summary

Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00988975
Study type Interventional
Source Urogynecology Associates, Indiana
Contact Douglass S Hale, MD
Phone 317-962-6600
Email dhale@clarian.org
Status Recruiting
Phase N/A
Start date September 2009
Completion date December 2012
View Details
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