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

Urogynecology Associates, Indiana

Status: Unknown

Conditions: Rectocele

Treatments: Procedure: Insertion of pelvicol graft

Study type: Interventional

Funder types: Other

Identifiers

NCT00988975

09-046

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Pelvicol graft

Active Comparator group

Treatment:

Procedure: Insertion of pelvicol graft

No graft material

No Intervention group

Description:

No graft material