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Incisional Hernia Outcomes Study

This study has been terminated.
(Principal investigator left institution.)
Sponsor:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00459602
First received: April 10, 2007
Last updated: October 10, 2008
Last verified: October 2008
History of Changes
  Purpose

The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.


Condition Intervention Phase
Incisional Hernia
 Procedure: laparoscopic incisional hernia repair
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multi-Center, Laparoscopic Abdominal-Wall Hernia Repair Outcomes Study Using Parietex Composite Mesh

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Columbia University:

Estimated Enrollment: 25
Study Start Date: August 2004
Estimated Study Completion Date: December 2009
Intervention Details:
    Procedure: laparoscopic incisional hernia repair

    This study is designed to look at outcomes. This is a baseline study with no interventions. Subjects with an incisional, ventral, umbilical, or spigelian hernia no larger tham 15 cm at the largest measurement, who are candidates for laparoscopic repair of the hernia, and who are able to commit to long-term followup will be invited to participate in this study.

    Laparoscopic repair of the hernia will proceed as per the standard technique, using polyester mesh. This standard technique is NOT EXPERIMENTAL OR INVESTIGATIONAL. It is the method currently used to repair abdominal wall hernias, and the method which would be used if a person declined participation in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgical clinic

Criteria

Inclusion Criteria:

  • incisional hernia suitable for repair by laparoscopic techniques

Exclusion Criteria:

  • not a candidate for laparoscopic surgery
  • hernia not suitable for laparoscopic repair techniques
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459602

Locations
United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Dennis L Fowler, MD Columbia University College of Physicians and Surgeons
  More Information

No publications provided

Responsible Party: Dennis Fowler, Columbia University
ClinicalTrials.gov Identifier: NCT00459602     History of Changes
Other Study ID Numbers: AAAA7985
Study First Received: April 10, 2007
Last Updated: October 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
laparoscopic surgery

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013