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

NCT ID: NCT06369597

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Liver Cancer; Renal Cancer; Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic telesurgery

Patients with liver cancer, renal cancer, rectal cancer will be treated by telesurgery.

Group Type: EXPERIMENTAL

Robotic telesurgery

Intervention Type: PROCEDURE

Telesurgery by domestic surgical robot

Laparoscopic surgery

Patients with liver cancer, renal cancer, rectal cancer will be treated by laparoscopic surgery.

Group Type: ACTIVE_COMPARATOR

Laparoscopic surgery

Intervention Type: PROCEDURE

Local laparoscopic surgery

Interventions

Robotic telesurgery

Telesurgery by domestic surgical robot

Intervention Type: PROCEDURE

Laparoscopic surgery

Local laparoscopic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kuang Ming, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Sun Yat-sen University

Locations

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Kuang Ming, PhD

Role: CONTACT

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Facility Contacts

Kuang Ming, PhD

Role: primary

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Other Identifiers

Robot2024

Identifier Type: -

Identifier Source: org_study_id