Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
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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 |
- 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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men with inguinal hernia.
Exclusion Criteria:
Contacts and 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 | |
| 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 May 16, 2013