Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Time to functional recovery
研究概览
简要总结
The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting.
The primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.
详细描述
Robotic-assisted surgery is hypothesised to reduce time to functional recovery by 2 days compared with open surgery. With a power of 80% and alpha of 0.05, the sample size needed in each arm to test superiority is 35 patients. With an expected 25% drop-out rate, 47 patients will be randomized in each group, with a total of 94 patients to be randomized in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.
- •Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.
排除标准
- •Previous extensive surgery in the upper abdomen (for example open liver surgery)
- •Pregnancy
- •Intraoperative findings of dissemination (patient is then excluded after randomization)
- •Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).
- •Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)
结局指标
主要结局
Time to functional recovery
时间窗: Days from operation
As defined as: 1. has adequate pain control with oral analgesics only (NRS\<5) 2. is independently mobile at the preoperative level 3. is able to maintain sufficient oral caloric intake (minimum of 50% required calories) 4. has no need for intravenous fluid administration 5. has no clinical signs of infection or infection treated with peroral antibiotics only
次要结局
- Quality of life of patients(1 year)
- Abdominal wall complaints(1 year)
- Post-operative complications(Within 90 days from surgery)
- Length of hospital stay(Days)
- Number of retrieved lymph nodes(Within 6 weeks after surgery)
- Total cost(1 year)
研究者
Christian Sturesson
Associate professor
Karolinska University Hospital