A Prospective Cohort Study: Robotic-Assisted Laparoscopic Versus Open Surgery for Complicated Hepatolithiasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- initial stone clearance rate
研究概览
简要总结
The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis. Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible. The study aimed to evaluate the safety, feasibility, and efficacy of robot assist laparoscopic surgery for the treatment of complicated hepatolithiasis by contrast of open procedures.
详细描述
Robot-assisted laparoscopic operation is a safe and feasible treatment for selected patients with complicated hepatolithiasis, with an advantage over open surgery in the field of intraoperative blood loss, less hilar occlusion, lower transfusion rate, less postoperative hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with intrahepatic bile duct stones or hepatolithiasis.
- •Liver function > Child-pugh level B, no severe biliary cirrhosis, ICG ≤ 15%, the residual liver volume and standard liver volume ratio ≥ 40%. The conditions of open hepatectomy were achieved
- •Age: Between 18 to 70 years
- •Combined with severe liver atrophy hypertrophy syndrome, hepatic portal transposition or hilar biliary fibrosis / stenosis
- •Patients with good general condition, the conditions of open Anatomical Hepatectomy were achieved
- •Other organ lesions and previous biliary tract operation is not the absolute
排除标准
- •Written informed consent
- •Exclusion Criteria:
- •Patients with bad general condition or important organ lesions, liver resection could not be tolerated
- •Age:Younger than 18 or more than 70 years old
- •Malignant tumor recurrence within one month postoperation
- •Complicated case need to get emergency operation
- •Contraindication of laparoscopy: Combined with complicated acute cholangitis, repeated biliary tract operation, heavy intra-abdominal adhesion, Trocar can not be placed in. Artificial pneumoperitoneum could not be tolerated
研究组 & 干预措施
Robot-assisted Laparoscopic operation
Da Vinci surgical robot can overcome limitations of conventional laparoscopic surgery in terms of vision and instrumentation flexibility, making the minimally invasive treatment of complex hepatolithiasis possible.
干预措施: Robot-assisted Laparoscopic operation (Procedure)
Open surgery
The indication of laparoscopic surgery is mainly for early regional type hepatolithiasis. Open surgery is the traditional treatment method for heptolithiasis.
干预措施: open surgery (Procedure)
结局指标
主要结局
initial stone clearance rate
时间窗: during the operation
rate of the removal of the stones from intrahepatic bile duct identified by ultrasonic or computed tomography or magnetic resonance
次要结局
- intraoperative parameters(during the operation)
研究者
Shuguo Zheng, MD
Professor of Hepatobiliary Surgery Institute; Chief Physician; Administrator of laparoscopic department
Southwest Hospital, China