The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial
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
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RESEARCH DESIGN/METHODS/SUBJECT JUSTIFICATION
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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.
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Comparison of operative times between groups as an estimation of operative ease in performing the different procedures.
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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
