NCT02871583已完成不适用
The Evaluation of Trunk Muscle Strength, Quality of Life, and Neuropathic Pain Component After Two Different Inguinal Hernia Repair Techniques; A Prospective Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- isokinetic muscle strength
研究概览
简要总结
The aim of the present prospective controlled study is to compare the trunk muscle strength, quality of life and neuropathic pain component after Lichtenstein and Kugel procedures.
详细描述
In this study patients underwent inguinal hernia repair will be evaluated for the effect of the surgical procedure on abdominal muscle strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Male gender (for minimizing the certain effect of gender to muscle strength)
- •Patients aged 18-65 years' old
- •Having no previous surgery
- •Patients within six months to postoperative first year
- •Ability to speak, read, and write Turkish
排除标准
- •Infections or tumors of the spine
- •Systemic bone or joint disorders (e.g., rheumatoid arthritis)
- •Unstable cardiovascular and pulmonary diseases
- •Polyneuropathies and musculoskeletal system diseases
- •Presence of a diagnosed severe psychiatric disorder
- •Presence of severe pain
- •Regular exercise habit
- •Recurrent operation for a hernia
- •Presence bilateral inguinal hernia on concurrent femoral hernia
- •If the calculated Body mass index is lower than 20kg/cm2 or over than 35kg/cm2
研究组 & 干预措施
Kugel
Active Comparator
Kugel procedure
干预措施: Kugel (Procedure)
control
No Intervention
healthy volunteers
lichtenstein
Active Comparator
lichtenstein procedure
干预措施: lichtenstein (Procedure)
结局指标
主要结局
isokinetic muscle strength
时间窗: 6 - 12 months
Trunk muscle strength measurement using the Biodex System 3Pro Multi-joint System Isokinetic dynamometer. Peak torque (PT) and PT-based agonist/antagonist ratios will be used to reveal strength imbalances.
次要结局
- quality of life assesment(6 -12 months)
研究者
Barış Sevinç
principle investigator
Konya Meram State Hospital
研究点 (1)
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