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Sponsored by: |
Federal University of São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00827528 |
The objective of this study is to evaluate surgical treatment of anterior vaginal wall prolapse using the sis graft or traditional repair. This a randomized and prospective study. Clinical patterns that will be evaluated: impact of surgery in quality of life using the Pelvic Organ Prolapse Questionnaire (P-QoL), anatomic results of surgery and possible complications.
Condition | Intervention | Phase |
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Pelvic Organ Prolapse |
Procedure: Traditional correction of anterior vaginal wall prolapse Procedure: Biologic Graft (SIS) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Surgical Treatment of Anterior Vaginal Wall Prolapse: Comparison of SIS Graft and Traditional Repair. |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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SIS graft: Experimental
this group will use a biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse.
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Procedure: Biologic Graft (SIS)
Biologic graft (SIS - Small Intestine Submucosa) in correction of anterior vaginal wall prolapse. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery. |
2: Active Comparator
this group will use a traditional repair on correction of anterior vaginal wall prolapse.
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Procedure: Traditional correction of anterior vaginal wall prolapse
Traditional repair. Patients diagnosed with anterior vaginal wall prolapse will be submitted to surgical correction. They will be randomized to receive a traditional repair or a graft in surgery. |
Ages Eligible for Study: | 30 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paulo C Feldner Jr, MD | 55-11-55739228 | pfeldner@terra.com.br |
Brazil, São Paulo/SP | |
Federal University of São Paulo | Recruiting |
São Paulo, São Paulo/SP, Brazil, 04025-001 | |
Contact: Paulo C Feldner Jr, MD 55-11-5573-9228 pfeldner@terra.com.br | |
Principal Investigator: Paulo C Feldner Jr, MD |
Study Chair: | Manoel João BC Girão, PhD | Department of Gynecology, Federal University of São Paulo |
Principal Investigator: | Paulo C Feldner Jr, MD | Department of Gynecology, Federal University of São Paulo |
Responsible Party: | Department of Gynecology - Federal university of São Paulo ( Paulo Cezar Feldner Jr, MD ) |
Study ID Numbers: | SISAPI 01 |
Study First Received: | January 21, 2009 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00827528 History of Changes |
Health Authority: | Brazil: Ethics Committee |
Pelvic Organ Prolapse Surgical Treatment |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |
Pathological Conditions, Anatomical Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Prolapse Rectal Prolapse |