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

NCT06369597 | Not Yet Recruiting

• 1 other identifier: Robot2024
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Renal Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  One month after surgery

Secondary Outcomes (5)

• Surgical time (min)

  One month after surgery

• Intraoperative blood loss (mL)

  One month after surgery

• Postoperative hospitalization days

  One month after surgery

• Physician satisfaction

  One month after surgery

• Remote metrics

  One month after surgery

Study Arms (2)

Robotic telesurgery

EXPERIMENTAL

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

Procedure: Robotic telesurgery

Laparoscopic surgery

ACTIVE COMPARATOR

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

Procedure: Laparoscopic surgery

Interventions

Robotic telesurgery PROCEDURE

Telesurgery by domestic surgical robot

Robotic telesurgery

Laparoscopic surgery PROCEDURE

Local laparoscopic surgery

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \~ 1.
• Child-Pugh score 5 \~ 7.
• 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 \~ 1.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Kidney Neoplasms; Rectal Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Kuang Ming, PhD

  First Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang Ming, PhD

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 17, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)