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
Recruitment status was Recruiting
Sponsor:
Urogynecology Associates, Indiana
Information provided by:
Urogynecology Associates, Indiana
ClinicalTrials.gov Identifier:
NCT00988975
First received: September 30, 2009
Last updated: October 1, 2009
Last verified: October 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 30, 2009 | ||||
| Last Updated Date | October 1, 2009 | ||||
| Start Date ICMJE | September 2009 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anatomic success of rectocele repair [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00988975 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
change in patient symptomatology post-operatively [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging | ||||
| Official Title ICMJE | Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy? | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE | Rectocele | ||||
| Intervention ICMJE | Procedure: Insertion of pelvicol graft
Pelvicol graft |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00988975 | ||||
| Other Study ID Numbers ICMJE | 09-046 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Douglass Hale, MD, Urogynecology Associates | ||||
| Study Sponsor ICMJE | Urogynecology Associates, Indiana | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Urogynecology Associates, Indiana | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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