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Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
This study has been completed.
First Received: March 20, 2002   Last Updated: January 20, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Collaborator: American College of Surgeons
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032448
  Purpose

Inguinal hernia is one of the most common worldwide afflictions of men. The presence of an inguinal hernia is indication for its repair. Approximately 700,000 hernia repairs are performed in the U.S. each year, and this procedure accounts for 10% of all general surgery procedures in the Veterans Health Administration (VHA) (10,000 inguinal herniorrhaphies performed per year). There are many different techniques currently in use for repairing inguinal hernias and with the advent of laparoscopy, yet another technique is being advocated. Laparoscopic repair has been reported in some studies to be superior to open repair because of less pain and earlier return to work. However, laparoscopic repair requires a general or regional anesthetic and expensive equipment and supplies to perform. There is also evidence that open tension-free mesh repair may have results similar to laparoscopic repair for these patient centered outcome measures. The general acceptance of this procedure, especially in the VHA, has not been uniform. Furthermore, no randomized trial of sufficient size and power to be conclusive has been done to set forth the operative "gold standard" for hernia repair.


Condition Intervention Phase
Hernia
Procedure: Standardized tension-free herniorrhaphy with prosthesis
Procedure: Standardized preperitoneal repair with prosthesis, using either a transperitoneal or extraperitoneal approach.
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: CSP #456 - Tension Free Inguinal Hernia Repair: Comparison of Open and Laparoscopic Surgical Techniques

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 2200
Study Start Date: October 1998
Estimated Study Completion Date: December 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Men with inguinal hernia.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032448

Locations
United States, Alabama
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
United States, Arkansas
Little Rock VA Medical Center
Little Rock, Arkansas, United States, 72205-5484
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
West Los Angeles VA Medical Center
West Los Angeles, California, United States, 90073
United States, Florida
Tampa VA Medical Center
Tampa, Florida, United States, 33612
United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston VA Medical Center
Boston, Massachusetts, United States, 02130
United States, Michigan
Detroit VA Medical Center
Detroit, Michigan, United States, 48201
United States, Missouri
Columbia VA Medical Center
Columbia, Missouri, United States
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
United States, Tennessee
Memphis VA Medical Center
Memphis, Tennessee, United States, 38104
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Houston VA Medical Center
Houston, Texas, United States, 77030-2498
United States, Utah
Salt Lake City VAMC
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
American College of Surgeons
  More Information

No publications provided

Study ID Numbers: 456
Study First Received: March 20, 2002
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00032448     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
tension-free herniorrhaphy
laparoscopic herniorrhaphy
Hernia

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on November 25, 2009