A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Surgical complication
研究概览
简要总结
This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery.
详细描述
First, a safety run-in trial for robotic telesurgery will be conducted and evaluated according to "3+3 design". At least 3 patients of each cancer type (including liver cancer,renal cancer and rectal cancer) will be enrolled for robotic telesurgery. If there is a tumor type for which the prior safety trial is terminated, the subsequent randomized controlled trial will not include patients of that type.
Second, after passing the safety run-in trial, a randomized controlled trial will be performed. New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery group(control group) or the robotic telesurgery group (intervention group) (84 patients in each group, 168 patients in total) in a 1:1 two-group parallel design.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver Cancer:
- •Age 18 - 75 years.
- •Clinical diagnosis of primary hepatocellular carcinoma or benign tumor such as hepatic adenoma.
- •Patients with hepatocellular carcinoma (BCLC stage 0-B) who were considered suitable for laparoscopic or robotic partial hepatectomy after MDT discussion, or benign tumor such as liver adenoma.
- •ECOG score 0 ~
- •Child-Pugh score 5 ~
- •Renal cancer:
- •Age 18 - 75 years old.
- •Clinical diagnosis of renal cancer (cT1-T2) or benign tumor such as renal malformation tumor.
- •Patients with benign tumors such as renal cancer (cT1-T2) or renal staggered tumor who were considered amenable to laparoscopic or robotic partial nephrectomy after MDT discussion.
- •ECOG score 0 ~
- •Rectal cancer:
- •Age 18 - 75 years old.
- •Clinical diagnosis of rectal cancer (Stage I-III).
- •Patients with primary rectal cancer who are considered amenable to laparoscopic or robotic radical rectal adenocarcinoma surgery after MDT discussion.
- •ECOG score 0 ~ 1.
排除标准
- •Liver Cancer:
- •Pregnant and lactating women.
- •Combination of other malignant tumors or other malignant tumors within 5 years before enrollment.
- •Recipients of allogeneic organ transplantation.
- •Severe dysfunction of heart, lung, kidney and other organs.
- •Renal cancer:
- •Pregnant and lactating women.
- •Lymph node metastasis, metastasis to other organs, previous surgical history of renal cancer, or any situation that cannot accept general anesthesia.
- •Combination of other malignant tumors or combination of other malignant tumors within 5 years prior to enrollment.
- •allogeneic organ transplant recipients.
- •Severe dysfunction of heart, lungs, kidneys and other organs.
- •Rectal cancer:
- •patients with stage IV or complicated disease and emergency surgery.
- •Pregnant and lactating women.
- •Combination of other malignant tumors or combination of other malignant tumors within 5 years before enrollment.
- •Allogeneic organ transplant recipients.
- •Severe dysfunction of heart, lung, kidney and other organs.
结局指标
主要结局
Surgical complication
时间窗: One month after surgery
Overall complication events within 30 days of surgery or intraoperative emergency intermediate open surgery events as defined by the Clavin-Dindo grading system
次要结局
- Physician satisfaction(One month after surgery)
- Surgical time (min)(One month after surgery)
- Postoperative hospitalization days(One month after surgery)
- Intraoperative blood loss (mL)(One month after surgery)
- Remote metrics(One month after surgery)
研究者
Ming Kuang
Professor
Sun Yat-sen University