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

Status unconfirmed · Not applicable

Conditions studied: Rectocele

In brief

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.

Key facts

Study ID

NCT00988975

Run by

Urogynecology Associates, Indiana

People needed

120

Starts

2009-09-01

Expected to finish

2012-12-01

Last updated by the study team

2009-10-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

You may not qualify if…

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

Where it is running

• Clarian North — Carmel, Indiana, United States (enrolling)
• Clarian Methodist — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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