Study Stopped
Inadequate accrural rates
Sponsor study identifier
observational
23
1 country
1
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
October 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2007
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 27, 2006
Actual (reported)December 28, 2006
Actual (reported)October 2007
Actual (reported)Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain.
4 weeks
AD males with primary hernia
Naval Medical Center Department of Surgery
Portsmouth, Virginia, 23708, United States
Paul A Lucha, DO
Naval Medical Center Department of Surgery- Portsmouth, VA
23 participants (actual enrollment reported by the registry).
First Submitted
December 27, 2006
First Posted
December 28, 2006
Study Start
March 2006
Date type not reportedThis date has not been verified as actual or estimated.
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
Contact the study team to confirm eligibility.
Study Completion
October 2007
Actual (reported)Last Updated
December 5, 2007
Record last verified: 2007-12
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Source: ClinicalTrials.gov.
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