Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
CSP #456 - Tension Free Inguinal Hernia Repair: Comparison of Open and Laparoscopic Surgical Techniques
1 other identifier
interventional
2,200
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 1998
Longer than P75 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1998
CompletedFirst Submitted
Initial submission to the registry
March 20, 2002
CompletedFirst Posted
Study publicly available on registry
March 22, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedApril 14, 2011
April 1, 2011
5.2 years
March 20, 2002
April 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess recurrence rates, operative complications, pain, convalescent time, health-related quality of life, patient satisfaction, and health care utilization and costs.
Two years
Study Arms (1)
1
OTHEROpen and laparoscopic herniorrhaphy
Interventions
Compare the effect of two typs of operative treatment of inguinal hernia.
Eligibility Criteria
You may qualify if:
- Men with inguinal hernia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- American College of Surgeonscollaborator
Study Sites (14)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073, United States
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
WJB Dorn Veterans Hospital, Columbia
Columbia, South Carolina, 29209, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, 84148, United States
Related Publications (1)
Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
PMID: 15107485RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leigh A. Neumayer
VA Salt Lake City Health Care System, Salt Lake City
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 20, 2002
First Posted
March 22, 2002
Study Start
October 1, 1998
Primary Completion
December 1, 2003
Study Completion
June 1, 2004
Last Updated
April 14, 2011
Record last verified: 2011-04