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

October 1, 2009 updated by: Urogynecology Associates, Indiana

Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • Clarian North
        • Principal Investigator:
          • Douglass S Hale, MD
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Clarian Methodist
        • Principal Investigator:
          • Douglass S Hale, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anatomic success of rectocele repair
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in patient symptomatology post-operatively
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urogynecology Associates, Indiana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (Estimate)

October 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2009

Last Update Submitted That Met QC Criteria

October 1, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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