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

• Sponsor: Urogynecology Associates, Indiana (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00988975
• Collaborator: (none)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 60
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectocele	Procedure: Insertion of pelvicol graft	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pelvicol graft	Procedure: Insertion of pelvicol graft; Pelvicol graft
No Intervention: No graft material No graft material

Outcome Measures

Primary Outcome Measures

1. Anatomic success of rectocele repair [6 months]

Secondary Outcome Measures

1. change in patient symptomatology post-operatively [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clarian North	Carmel	Indiana	United States	46032
2	Clarian Methodist	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Urogynecology Associates, Indiana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00988975
• Other Study ID Numbers: 09-046
• First Posted: Oct 2, 2009
• Last Update Posted: Oct 2, 2009
• Last Verified: Oct 1, 2009

• Additional relevant MeSH terms: Rectocele

Study Results

No Results Posted as of Oct 2, 2009