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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00988975 |
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Date of registration:
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30/09/2009 |
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Primary sponsor: |
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Public title:
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Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging
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Scientific title:
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Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy? |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00988975 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Douglass S Hale, MD |
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Address:
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Telephone:
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317-962-6600 |
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Email:
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dhale@clarian.org |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Rectocele
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Intervention(s)
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Procedure: Insertion of pelvicol graft
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Primary Outcome(s)
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Anatomic success of rectocele repair
[Time Frame: 6 months]
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Secondary Outcome(s)
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change in patient symptomatology post-operatively
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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