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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01320644
First Posted: March 22, 2011
Last Update Posted: August 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
charbel salamon, Atlantic Health System
  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

Further study details as provided by charbel salamon, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320644


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

Responsible Party: charbel salamon, Principal Investigator, Atlantic Health System
ClinicalTrials.gov Identifier: NCT01320644     History of Changes
Other Study ID Numbers: R10-06-005
First Submitted: March 21, 2011
First Posted: March 22, 2011
Last Update Posted: August 11, 2016
Last Verified: August 2016

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

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