Clinical trial NCT06369597: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
Official title: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cancer
Renal Cancer
Rectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Surgical complication
timeFrame: One month after surgery
Secondary outcomes:
measure: Surgical time (min)
timeFrame: One month after surgery
measure: Intraoperative blood loss (mL)
timeFrame: One month after surgery
measure: Postoperative hospitalization days
timeFrame: One month after surgery
measure: Physician satisfaction
timeFrame: One month after surgery
measure: Remote metrics
timeFrame: One month after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital of Sun Yat-sen University
name: Kuang Ming, PhD
role: PRINCIPAL_INVESTIGATOR
References: