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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Renal Cancer; Liver Cancer; Rectal Cancer

Treatments: Procedure: Robotic telesurgery; Procedure: Laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06369597

Robot2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 177 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

Robotic telesurgery

Experimental group

Description:

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

Treatment:

Procedure: Robotic telesurgery

Laparoscopic surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Laparoscopic surgery