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NCT00032448 · ClinicalTrials.gov registry record · Phase 3
Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,200
- Enrollment target
NCT00032448 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 2,200 participants.
The verdict
NCT00032448, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,200 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Standardized tension-free herniorrhaphy with prosthesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,200 participants |
| Start Date | 1998-10 |
| Est. Completion | 2004-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00032448
The ClinicalTrials.gov registry entry for NCT00032448 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Standardized tension-free herniorrhaphy with prosthesis is the first listed.
NCT00032448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00032448 about?
NCT00032448 is a clinical study titled "Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?". 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 Hea...
What is the current status of trial NCT00032448?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,200 participants. The study started on 1998-10. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00032448?
The interventions under investigation include: Standardized tension-free herniorrhaphy with prosthesis (PROCEDURE).
Who is sponsoring clinical trial NCT00032448?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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