跳至主要内容
临床试验/NCT00416364
NCT00416364终止不适用

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

United States Naval Medical Center, Portsmouth1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
23
试验地点
1
主要终点
Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain.

研究概览

简要总结

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.

详细描述

  1. RESEARCH DESIGN/METHODS/SUBJECT JUSTIFICATION

  2. General Approach To randomize between Lichtenstein, PHS, GBP,and MPR hernia repair in a double blinded fashion in patients presenting to the general surgery clinic with primary unilateral inguinal hernias. . Daily visual analogue pain scales (validated for this purpose) will be obtained. An SF 12, quality of life instrument, validated for this purpose will be provided on a weekly basis to assess impact, if any, that differing hernia repairs may have. This instrument has been validated to provide serial assessments in quality of life in surgical patients.

(1) Research Objective 2. Comparison of operative costs between groups. 3. Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain.

  1. Comparison of operative times between groups as an estimation of operative ease in performing the different procedures.

  2. Comparison of Quality of life suveys (SF 12) serially between groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Unilateral primary inguinal hernia presenting for repair

排除标准

  • •Recurrent repairs
  • •Bilateral repairs
  • •Repairs done with other operative procedures

结局指标

主要结局

Comparison of Visual Analogue Pain Scale between groups to assess differences in percieved postoperative pain.

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方
United States Naval Medical Center, Portsmouth
申办方类型
Fed

研究点 (1)

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