Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 试验地点
- 2
- 主要终点
- Time until full functional recovery
研究概览
简要总结
Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.
详细描述
Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.
472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 30-75 years
- •Primary inguinal hernia
- •ASA I-III
排除标准
- •> 75 years
- •Previous ipsi-lateral hernia surgery
- •Drug or alchol abuse
- •Severe illness
结局指标
主要结局
Time until full functional recovery
时间窗: 2 weeks, 3 months, 1 year, 3 years
Operation time
时间窗: Registered after completion of surgery
Pain after operation measured on a VAS-scale and amount of consumed analgesics
时间窗: Day 1-14, 3 months, 1 year, 3 years after surgery
次要结局
- Complication rate(2 weeks, 3 months, 1 year, 3 years)
- Aptness for beeing performed under local anaesthesia(During surgery)