3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Duration of surgery
研究概览
简要总结
Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. The three-dimensional laparoscopic systems are gradually entering the operating rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions. However, no prospective randomized trials have been published in the clinical point of view. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic inguinal hernia repair
排除标准
- •Some other surgical operation planned during TAPP
- •Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis)
- •Operating surgeon experience less than 5 3D laparoscopy operations
研究组 & 干预措施
2D TAPP
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view
干预措施: 2D laparoscopic TAPP inguinal hernia repair (Procedure)
3D TAPP
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view
干预措施: 3D laparoscopic TAPP inguinal hernia repair (Procedure)
结局指标
主要结局
Duration of surgery
时间窗: Expected average time of surgery 1 hour
次要结局
- Total need of opioids in milligrams(Expected range 0-7 day)
- Intraoperative complications(During the operation, expected average time of surgery 1 hour)
- Need for conversion into open surgery(During the operation, expected average time of surgery 1 hour)
- Bleeding(During the operation, expected average time of surgery 1 hour)
- Postoperative stay in hospital(Expected range 0-7 day)
- Number of participants with readmission(s)(30 days after randomization)
- Mortality(30 days after randomization)
- Complications, Clavien-Dindo classification(30 days after randomization)
- Operation theatre time(Expected average 1,5 hours)
- Postoperative pain, VAS(Expected range 0-7 day)
研究者
Hanna Koppatz
MD
Helsinki University Central Hospital