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

Sponsor

Atlantic Health System (Other)

Overall Status

Completed

CT.gov ID

NCT01055860

Collaborator

(none)

Enrollment

Location

16.9

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Urinary Incontinence

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Robotic sacral colpopexy Our study population will be women who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapse using a synthetic polypropylene mesh.

Outcome Measures

Primary Outcome Measures

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

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]