Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 16, 2008 |
| Last Updated Date | January 25, 2010 |
| Start Date ICMJE | October 2007 |
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit [ Time Frame: 1 year post operatively ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00774215 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit [ Time Frame: 1 year ] [ 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 | Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year |
| Official Title ICMJE | Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse |
| Brief Summary | This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit. |
| Detailed Description | This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh "kit" from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms. This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | All patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08. |
| Condition ICMJE | Pelvic Organ Prolapse |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* 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 | Completed |
| Estimated Enrollment ICMJE | 103 |
| Completion Date | April 2009 |
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Female |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00774215 |
| Other Study ID Numbers ICMJE | R07-09-016 |
| Has Data Monitoring Committee | No |
| Responsible Party | Patrick Culligan, MD, Director, Division of Urogynecology & Reconstructive Pelvic Surgery, Atlantic Health System |
| Study Sponsor ICMJE | Atlantic Health System |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Atlantic Health System |
| Verification Date | October 2008 |
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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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