A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery

Sun Yat-sen University177 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

177

Conditions

Liver Cancer Renal Cancer Rectal Cancer

Interventions

Robotic telesurgeryPROCEDURE

Telesurgery by domestic surgical robot

Laparoscopic surgeryPROCEDURE

Local laparoscopic surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Liver Cancer: 1. Age 18 - 75 years. 2. Clinical diagnosis of primary hepatocellular carcinoma or benign tumor such as hepatic adenoma. 3. 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. 4. ECOG score 0 \~ 1. 5. Child-Pugh score 5 \~ 7. * Renal cancer: 1. Age 18 - 75 years old. 2. Clinical diagnosis of renal cancer (cT1-T2) or benign tumor such as renal malformation tumor. 3. 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. 4. ECOG score 0 \~ 1. * Rectal cancer: 1. Age 18 - 75 years old. 2. Clinical diagnosis of rectal cancer (Stage I-III). 3. Patients with primary rectal cancer who are considered amenable to laparoscopic or robotic radical rectal adenocarcinoma surgery after MDT discussion. 4. ECOG score 0 \~ 1. Exclusion Criteria: * Liver Cancer: 1. Pregnant and lactating women. 2. Combination of other malignant tumors or other malignant tumors within 5 years before enrollment. 3. Recipients of allogeneic organ transplantation. 4. Severe dysfunction of heart, lung, kidney and other organs. * Renal cancer: 1. Pregnant and lactating women. 2. Lymph node metastasis, metastasis to other organs, previous surgical history of renal cancer, or any situation that cannot accept general anesthesia. 3. Combination of other malignant tumors or combination of other malignant tumors within 5 years prior to enrollment. 4. allogeneic organ transplant recipients. 5. Severe dysfunction of heart, lungs, kidneys and other organs. * Rectal cancer: 1. patients with stage IV or complicated disease and emergency surgery. 2. Pregnant and lactating women. 3. Combination of other malignant tumors or combination of other malignant tumors within 5 years before enrollment. 4. Allogeneic organ transplant recipients. 5. Severe dysfunction of heart, lung, kidney and other organs.

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Surgical complication

Overall complication events within 30 days of surgery or intraoperative emergency intermediate open surgery events as defined by the Clavin-Dindo grading system