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NCT00416364 · ClinicalTrials.gov registry record

The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial

A clinical trial, sponsored by United States Naval Medical Center, Portsmouth.

Terminated
Registry status
23
Enrollment target

NCT00416364 is a clinical trial that was terminated before completion, run by United States Naval Medical Center, Portsmouth. The registered enrollment target is 23 participants.

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The verdict

NCT00416364 was terminated before completion, sponsored by United States Naval Medical Center, Portsmouth.

TERMINATED
Registry status
23 participants
Enrollment target

Study Summary

There are a variety of methods to repair inguinal hernias. Each has its advocate and may confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and economics have all been evaluated however none in a randomized blinded fashion. Recently, investigators have attempted to address some of these concerns with new prosthetic materials. The preferred method of repair currently employs a tension free technique using mesh prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal ring. Currently no study has compared these techniques for ease of performance, postoperative pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is uniquely qualified to compare these repairs prospectively and blinded to best assess the most cost effective approach which causes the least pain. A prospective double-blinded randomized trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on quality of life will be assessed serially with the SF 12 which is a validated survey used with serial measures in the acute setting.

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2006-03
Est. Completion 2007-10

What the Registry Record Tells You About NCT00416364

The ClinicalTrials.gov registry entry for NCT00416364 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Naval Medical Center, Portsmouth, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00416364 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00416364 about?

NCT00416364 is a clinical study titled "The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial". There are a variety of methods to repair inguinal hernias. Each has its advocate and may confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and economics have all been evaluated however none in a randomized blinded fashion. Recently, investigators have attempted...

What is the current status of trial NCT00416364?

This trial is currently terminated. The enrollment target is 23 participants. The study started on 2006-03. Estimated completion is 2007-10.

Who is sponsoring clinical trial NCT00416364?

This trial is sponsored by United States Naval Medical Center, Portsmouth, which has 7 total clinical trials registered on ClinicalTrials.gov.

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