One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Atlantic Health System1 site in 1 country75 target enrollmentFebruary 2009

ConditionsPelvic Organ Prolapse Urinary Incontinence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pelvic Organ Prolapse
Sponsor: Atlantic Health System
Enrollment: 75
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

July 2010

Last Updated

15 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Atlantic Health System

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: one year

Secondary Outcomes

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)