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Sponsored by: |
Atlantic Health System |
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Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00774215 |
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.
Condition |
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Pelvic Organ Prolapse |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Retrospective Cohort of the Avaulta Vaginal Mesh Procedure as a Treatment of Pelvic Organ Prolapse |
Estimated Enrollment: | 103 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Atlantic Health System - Division of Urogynecology | |
Morristown, New Jersey, United States, 07960 |
Study Director: | Paul M Littman, DO | Atlantic Health Systemt - Division of Urogynecology |
Responsible Party: | Atlantic Health System ( Patrick Culligan, MD, Director, Division of Urogynecology & Reconstructive Pelvic Surgery ) |
Study ID Numbers: | R07-09-016 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774215 |
Health Authority: | United States: Institutional Review Board |
Pelvic Organ Prolapse Cystocele Rectocele Enterocele |
Synthetic Mesh Vaginal Mesh Transobturator |
Pathological Conditions, Anatomical Rectocele Digestive System Diseases Cystocele Ataxia-Telangiectasia Gastrointestinal Diseases |
Urinary Bladder Diseases Ataxia Telangiectasia Intestinal Diseases Rectal Diseases Prolapse Rectal Prolapse |