Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs
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
- patient ability to resume domestic activity independently
研究概览
简要总结
This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.
详细描述
The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •adult male primary inguinal hernia
排除标准
- •recurrent hernia previous lower abdominal surgery [excluding appendectomy]
研究组 & 干预措施
open properitoneal
patients undergoing open properitoneal hernia repair
干预措施: open properitoneal hernia repair (Procedure)
Lechtenstien repair
Patients undergoing Lechtestien hernia repair
干预措施: Lechtestien hernia repair (Procedure)
Laparoscopic transperitoneal repair
Patients undergoing TAPP repair
干预措施: Laparoscopic transperitoneal approach (Procedure)
Lap totally extraperitoneal approach
Patients undergoing TEP approach
干预措施: Laparoscopic totally extraperitoneal approach (Procedure)
结局指标
主要结局
patient ability to resume domestic activity independently
时间窗: daily reporting by the patient
次要结局
- time of the patient to return to work(reported by the patient)