A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh (ALYTE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jodie Komar, Atlantic Health System
ClinicalTrials.gov Identifier:
NCT01320644
First received: March 21, 2011
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.


Condition
Pelvic Organ Prolapse
Urinary Incontinence
Mesh Erosion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

Enrollment: 150
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
vaginal mesh placement

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study population will be woman who underwent robotic assisted laparoscopic sacral colpopexy at Morristown Memorial Hospital for the correction of pelvic organ prolapse using synthetic polypropylene mesh

Criteria

Inclusion Criteria:

  • Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh
  • >21 y.o

Exclusion Criteria:

  • Graft material other than polypropylene mesh
  • Enrollment in another study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320644

Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
  More Information

No publications provided

Responsible Party: Jodie Komar, PI, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320644     History of Changes
Other Study ID Numbers: R10-06-005
Study First Received: March 21, 2011
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Atlantic Health System:
Uterine prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Urinary Incontinence
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 21, 2014