A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

Surgery Clinical Trial

Official title:

A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06353672
• Other study ID #: RLR-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. Several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. Previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (RLR) over laparoscopic liver resection (LLR) or open liver resection (OLR), considering the various degrees of difficulty in liver surgeries. This study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with LLR or OLR, and gain veritable and relevant data on the benefits of RLR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The patients were diagnosed with a liver tumor.
• The patients underwent robotic liver resection.

Exclusion Criteria:

• The patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).

Related Conditions & MeSH terms

• Liver Diseases
• Surgery

Intervention

Device:
• Robotic liver resection
Liver resection using Da Vinci robotic system

Locations

Country	Name	City	State
China	First Affiliated Hospital, Medical College of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	The grades of postoperative complications were recorded following the Clavien-Dindo classification. Partial hepatic dysfunction or hepatic failure, biliary fistula, postoperative hemorrhage, pleural effusion, venous thrombosis, and surgical site infections were recorded.	with in 90 days after surgery
Primary	Postoperative hospital stay	The days of hospital stay after operation	with in 90 days after surgery
Primary	Postoperative unplanned reoperation	The unplanned reoperation due to postoperative complications	with in 90 days after surgery
Primary	Unplanned readmission	The unplanned readmission after discharge due to postoperative complications	with in 90 days after surgery