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| Sponsors and Collaborators: |
Department of Veterans Affairs 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 |
| MedlinePlus related topics: | Hernia |
| 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 |
| Estimated Enrollment: | 2200 |
| Study Start Date: | October 1998 |
| Estimated Study Completion Date: | December 2003 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Men with inguinal hernia.
Contacts and 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 | |||||
| Department of Veterans Affairs |
| American College of Surgeons |
More Information
| Study ID Numbers: | 456 |
| First Received: | March 20, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00032448 |
| Health Authority: | United States: Federal Government |
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