NCT01637818已完成不适用
Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 594 人开始时间: 1999年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 594
- 试验地点
- 1
- 主要终点
- Recurrence
研究概览
简要总结
Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."
Primary endpoints is recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 39 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
- •provision of written informed consent,
- •symptomatic unilateral or bilateral inguinal hernia.
排除标准
- •presence of a femoral hernia,
- •history of hernia repair with mesh,
- •type I diabetes,
- •presence of local or diffuse infection (urine, skin, lung, sepsis),
- •immune deficiency,
- •severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,
- •pregnancy,
- •malignant tumours and
- •life expectancy of less than 2 years
研究组 & 干预措施
Lichtenstein's Operation
Other
干预措施: Paracetamol (Drug)
Lichtenstein's Operation
Other
干预措施: non-steroidal anti-inflammatory drug (Drug)
Mesh Plug Repair
Other
干预措施: Mesh Plug Repair (Procedure)
Mesh Plug Repair
Other
干预措施: Opiate (Drug)
Lichtenstein's Operation
Other
干预措施: Lichtenstein's operation (Procedure)
Lichtenstein's Operation
Other
干预措施: Opiate (Drug)
Mesh Plug Repair
Other
干预措施: Paracetamol (Drug)
Mesh Plug Repair
Other
干预措施: non-steroidal anti-inflammatory drug (Drug)
结局指标
主要结局
Recurrence
时间窗: 6 years
Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)
次要结局
- Reoperation(6 years)
- Pain(6 years)
- Sensitivity(6 years)
研究者
Raoul Droeser
MD
University Hospital, Basel, Switzerland
研究点 (1)
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