Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Inguinal Hernia Repair.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of errors during the dissection of the hernia sac
研究概览
简要总结
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in inguinal hernia repair in terms of error rating, performance time and subjective assessment.
详细描述
Experimental studies have shown that even experienced surgeons gain from stereoscopy when solving both easy and complex tasks. Inguinal hernia repair is a specialist operation and the large flow makes this type of operation suitable for exploring any advantage of three-dimensional laparoscopy for the experienced surgeon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective inguinal hernia repair (out-patient treatment)
排除标准
- •Previous lower abdominal surgery
- •ASA-score 3 or above
研究组 & 干预措施
2D HD laparoscopy
Elective laparoscopic inguinal hernia repair performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode
干预措施: 2D HD laparoscopy (Device)
3D HD laparoscopy
Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode
干预措施: 3D HD laparoscopy (Device)
结局指标
主要结局
Number of errors during the dissection of the hernia sac
时间窗: Expected duration: 20 minutes
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
次要结局
- Intraoperative complications(intraoperative, expected duration of surgery: 1 hour)
- Duration of the dissection of the hernia sac.(Expected duration: 20 minutes)
- Duration of surgery(Expected duration: 1 hour)
- The need for conversion to open surgery(intraoperative, expected duration of surgery: 1 hour)
- Assessment of fatigue and perceived exertion(an expected average of 15 minutes before and after the operation)
- Evaluation of the optical modality and mental load assessment(an expected average of 15 minutes after the operation)
- Estimated blood loss in ml(intraoperative, expected duration of surgery: 1 hour)