Randomized Controlled Trial Comparing Postoperative Pain And Early Outcomes After Robotic-Assisted Versus Open Renal Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
Kidney transplantation is the definitive treatment for end-stage renal disease, traditionally via open surgery (OKT) using a large incision. While effective, OKT carries significant risks of wound complications, especially in obese or diabetic patients. Robot-assisted kidney transplantation (RAKT) was developed using the da Vinci system to address these issues. RAKT offers a magnified 3D view and precise instruments, enabling smaller incisions and potentially reducing complications. However, comparative data on RAKT versus OKT remains limited and inconsistent due to small, retrospective studies. A new randomized controlled trial aims to directly compare these approaches. Its primary outcome is postoperative pain, with secondary measures including complications, recovery, and cost-effectiveness. This trial seeks to provide robust evidence to guide clinical practice and improve patient outcomes in transplant surgery.
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 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosed ESRD and eligible for living-donor renal transplantation.
排除标准
- •Cadaveric or ABO-incompatible transplant.
- •Significant iliac vascular calcification or abnormal anatomy requiring open exposure.
- •Multiple vessels, left iliac fossa transplant Vascular and ureteric anomalies of donor kidney Prior major pelvic surgery precluding robotic access.
- •BMI more than 40 kilogram per meter cube (if robotic limitation).
- •Severe cardiopulmonary disease prohibiting pneumoperitoneum.
研究者
Professor Virinder Kumar Bansal
AIIMS, New Delhi
