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

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ClinicalTrials.gov Identifier: NCT00988975
Recruitment Status : Unknown
Verified October 2009 by Urogynecology Associates, Indiana.
Recruitment status was:  Recruiting
First Posted : October 2, 2009
Last Update Posted : October 2, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Rectocele Procedure: Insertion of pelvicol graft

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Anatomic success of rectocele repair [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. change in patient symptomatology post-operatively [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988975

Contact: Douglass S Hale, MD 317-962-6600 dhale@clarian.org

United States, Indiana
Clarian North Recruiting
Carmel, Indiana, United States, 46032
Principal Investigator: Douglass S Hale, MD         
Clarian Methodist Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Douglass S Hale, MD         
Sponsors and Collaborators
Urogynecology Associates, Indiana

Responsible Party: Douglass Hale, MD, Urogynecology Associates
ClinicalTrials.gov Identifier: NCT00988975     History of Changes
Other Study ID Numbers: 09-046
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical