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

September 30, 2009
October 1, 2009
September 2009
December 2012   (final data collection date for primary outcome measure)
Anatomic success of rectocele repair [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988975 on ClinicalTrials.gov Archive Site
change in patient symptomatology post-operatively [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Rectocele
Procedure: Insertion of pelvicol graft
Pelvicol graft
  • Active Comparator: Pelvicol graft
    Intervention: Procedure: Insertion of pelvicol graft
  • No Intervention: No graft material
    No graft material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact: Douglass S Hale, MD 317-962-6600 dhale@clarian.org
United States
 
NCT00988975
09-046
No
Douglass Hale, MD, Urogynecology Associates
Urogynecology Associates, Indiana
Not Provided
Not Provided
Urogynecology Associates, Indiana
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP