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

Not Applicable

• Conditions: Rectocele
• Interventions: Procedure: Insertion of pelvicol graft

• Registration Number: NCT00988975
• Lead Sponsor: Urogynecology Associates, Indiana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Status Verified: 2009-10
• Study First Submitted QC: 2009-10-01
• Last Update Submitted: 2009-10-01
• Study First Posted: 2009-10-02
• Last Update Posted: 2009-10-02
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvicol graft	Insertion of pelvicol graft	-

Primary Outcome Measures

Name	Time	Method
Anatomic success of rectocele repair	6 months

Secondary Outcome Measures

Name	Time	Method
change in patient symptomatology post-operatively	6 months

Trial Locations

Locations (2)

Clarian Methodist; 🇺🇸 Indianapolis, Indiana, United States

Clarian North; 🇺🇸 Carmel, Indiana, United States