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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Urogynecology Associates, Indiana.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Urogynecology Associates, Indiana
ClinicalTrials.gov Identifier:
NCT00988975
First received: September 30, 2009
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

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 Intervention
Rectocele
Procedure: Insertion of pelvicol graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?

Resource links provided by NLM:


Further study details as provided by Urogynecology Associates, Indiana:

Primary Outcome Measures:
  • Anatomic success of rectocele repair [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in patient symptomatology post-operatively [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pelvicol graft Procedure: Insertion of pelvicol graft
Pelvicol graft
No Intervention: No graft material
No graft material

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988975

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

Locations
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
  More Information

No publications provided

Responsible Party: Douglass Hale, MD, Urogynecology Associates
ClinicalTrials.gov Identifier: NCT00988975     History of Changes
Other Study ID Numbers: 09-046
Study First Received: September 30, 2009
Last Updated: October 1, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014