A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

NCT06353672 | Recruiting

• 1 other identifier: RLR-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Diseases; Surgery

Keywords

Robotic liver resection

Outcome Measures

Primary Outcomes (4)

• 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

• Postoperative hospital stay

  The days of hospital stay after operation

  with in 90 days after surgery

• Postoperative unplanned reoperation

  The unplanned reoperation due to postoperative complications

  with in 90 days after surgery

• Unplanned readmission

  The unplanned readmission after discharge due to postoperative complications

  with in 90 days after surgery

Study Arms (1)

Robotic liver resection

EXPERIMENTAL

Device: Robotic liver resection

Interventions

Robotic liver resection DEVICE

Liver resection using Da Vinci robotic system

Robotic liver resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 9, 2024
• Study Start: December 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)