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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06369597
• Other study ID #: Robot2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Sun Yat-sen University
• Contact: Kuang Ming, PhD
• Phone: 008687755766
• Email: kuangm[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 177
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Neoplasms
• Liver Cancer
• Rectal Cancer
• Renal Cancer

Intervention

Procedure:
• Robotic telesurgery
Telesurgery by domestic surgical robot
• Laparoscopic surgery
Local laparoscopic surgery

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Surgical time (min)	Total time from the start of surgery after robotic or laparoscopic installation to the end of incision closure and the surgeon's operating time.	One month after surgery
Secondary	Intraoperative blood loss (mL)	Total bleeding from the start of surgery to the end of incision suturing.	One month after surgery
Secondary	Postoperative hospitalization days	Number of days from the day of surgery to the day of discharge.	One month after surgery
Secondary	Physician satisfaction	A NASA-TLX quantification form was completed by the physician postoperatively.	One month after surgery
Secondary	Remote metrics	Record data related to network transmission end-to-end latency time, jitter, and frame loss.	One month after surgery