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临床试验/CTRI/2026/03/107095
CTRI/2026/03/107095尚未招募2 期

Randomized Controlled Trial Comparing Postoperative Pain And Early Outcomes After Robotic-Assisted Versus Open Renal Transplantation

Professor. Virinder Kumar Bansal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月13日最近更新:

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

发起方
Professor. Virinder Kumar Bansal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Professor Virinder Kumar Bansal

AIIMS, New Delhi

研究点 (1)

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