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

NCT01055860 | Completed

• 1 other identifier: R09-02-007
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Keywords

uterine Prolapse; vaginal prolapse; mesh erosion; urinary incontinence; bowel symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

You may not qualify if:

• Other graft material than polypropylene.
• Enrollment in a different study.

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Atlantic Health Urogynecology

Morristown, New Jersey, 07960, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence; Uterine Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• Patrick Culligan, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

US (1)