A randomised controlled trial to compare the use of fan retractor and Nathanson retractor for operative view score after liver retraction in laparoscopic bariatric surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Operative view score
研究概览
简要总结
As the world of laparoscopy is emerging with advent of technology, touch is being lost but visualization has improved. An optimal operative field view is crucial for increasing quality and safety of a laparoscopic surgical procedure. The laparoscopic approach has become the new normal because of reduced risk for wound complications and enhanced cosmesis.
Liver retraction is crucial for providing adequate visualization and working space around the stomach during laparoscopic bariatric surgery. In bariatric surgery, the retraction is particularly challenging as the method employed must have the ability to lift the heavy liver adequately. Liver retraction is traditionally achieved through insertion of an external retractor through a laparoscopic port (fan retractor) or an incision (Nathanson retractor). Mechanical liver retractors are known to cause retraction related transamnitis.
In the existing literature, there are comparative studies of various retraction methods in terms of operative field view, chances of liver injury and retraction related post-operative complications. However, majority of these studies are descriptive in nature and direct comparisons between instruments and techniques would be complicated. Several lacunae exist in the current literature about the comparability of use of fan retractor, in terms of operative field view, with the commonly used Nathanson retractor.
Comparability studies related to operative field view as a primary objective need to be performed to define an optimal retractor in the Indian setting. In our study, in addition to operative view score, changes in the liver function tests and port/incision site pain post-operatively in two retraction groups will also be studied and compared. These studies would assist us in selecting appropriate device with optimal operative field view and less post-operative retraction related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing laparoscopic bariatric surgery with BMI less than 50 kg/m2 who consent to participate in the study.
排除标准
- •Patients who have undergone previous upper abdominal surgeries Patients with severe liver pathology, such as cirrhosis, hepatitis or extensive tumors.
结局指标
主要结局
Operative view score
时间窗: Intra-operatively after placement of retractor
次要结局
- Changes in liver function tests(Pre-operatively, Post-operatively at 24 hours, 1 week & 1 month)
- Post-operative pain using visual analog score(Post-operatively at 8 hours, 24 hours & 48 hours)
- Time for retractor insertion in minutes(Intra-operatively after placement of retractor)
研究者
Dr Amneet Kaur
Lady Hardinge Medical College and Associated Hospitals, New Delhi