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.
Sponsor:
Collaborator:
American College of Surgeons
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032448
First received: March 20, 2002
Last updated: April 13, 2011
Last verified: April 2011
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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:

Primary Outcome Measures:
  • To assess recurrence rates, operative complications, pain, convalescent time, health-related quality of life, patient satisfaction, and health care utilization and costs. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: October 1998
Study Completion Date: June 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Open and laparoscopic herniorrhaphy
Procedure: Standardized tension-free herniorrhaphy with prosthesis
Compare the effect of two typs of operative treatment of inguinal hernia.

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  Eligibility

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

Inclusion Criteria:

Men with inguinal hernia.

Exclusion Criteria:

  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: NCT00032448

Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, South Carolina
WJB Dorn Veterans Hospital, Columbia
Columbia, South Carolina, United States, 29209
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Leigh A. Neumayer VA Salt Lake City Health Care System, Salt Lake City
  More Information

Publications:
Responsible Party: Neumayer, Leigh - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032448     History of Changes
Other Study ID Numbers: 456
Study First Received: March 20, 2002
Last Updated: April 13, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014