Recruiting

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

Sponsor:

Urogynecology Associates, Indiana

Code:

NCT00988975

Conditions

Rectocele

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Insertion of pelvicol graft

Study Details

Brief 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.

Conditions

Rectocele

Study ID

NCT00988975

Start date

Sep, 2009

Status verified date

Oct, 2009

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion Criteria:

concomitant colo-rectal procedure
allergy to pork
any contraindication to laparoscopic sacrocolpopexy

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pelvicol graft

no intervention: No graft material

No graft material

Interventions

Insertion of pelvicol graft

Pelvicol graft

Primary outcome measure

Anatomic success of rectocele repair [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Douglass S Hale, MD

317-962-6600 dhale@clarian.org

Locations

Clarian North

Recruiting

Carmel, Indiana, United States, 46032

Principal Investigator:

Douglass S Hale, MD

Clarian Methodist

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Douglass S Hale, MD

More Information

Sponsor

Urogynecology Associates, Indiana

Last update posted

Oct 2, 2009

Last verified

Oct, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urogynecology Associates, Indiana on 2009-10-02.