One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review
Completed
- Conditions
- Pelvic Organ ProlapseUrinary Incontinence
- Registration Number
- NCT01055860
- Lead Sponsor
- Atlantic Health System
- Brief Summary
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 75
Inclusion Criteria
- Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period
Exclusion Criteria
- Other graft material than polypropylene.
- Enrollment in a different study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus one year
- Secondary Outcome Measures
Name Time Method 2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7) one year 3. Pelvic organ prolapse related symptoms (PFDI-20) one year 4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported. one year
Trial Locations
- Locations (1)
Atlantic Health Urogynecology
🇺🇸Morristown, New Jersey, United States