Comparison of clinical outcomes in Laparoscopic versus Robotic adrenalectomy for benign and malignant adrenal diseases: A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the clinical outcomes (Safety & Efficacy) between robotic and laparoscopic adrenalectomy in benign and malignant adrenal lesions.
研究概览
简要总结
This study is a Randomised Controlled Trial to compare the clinical outcomes (Safety & Efficacy) between robotic and laparoscopic adrenalectomy in benign and malignant adrenal lesions and also to assess the ease of doing the procedure by the surgeon between robotic and laparoscopic adrenalectomy and conversion to open in each approach. This will help us to realize which minimal access approach (robotics or Laparoscopic ) is better for patients to have a better clinical outcome postoperatively and also to determine the ease of doing surgery by surgeon and possibility of conversion to open procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years.
排除标准
- •Age below 18 yrs Refusal to give consent Patients not fit for general anesthesia and surgical positioning History of previous abdominal Surgeries.
结局指标
主要结局
To compare the clinical outcomes (Safety & Efficacy) between robotic and laparoscopic adrenalectomy in benign and malignant adrenal lesions.
时间窗: Safety and efficacy will be assessed at baseline after surgery and at 2 weeks and 6 weeks after surgery
次要结局
- To compare the ease of doing the procedure by the surgeon between robotic & laparoscopic adrenalectomy.(At baseline, just after the surgery)
- To compare the robotic & laparoscopic adrenalectomy in terms of conversion to open(adrenalectomy.)
研究者
Dr Kunal Soni
Kunal Soni