A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

Not Applicable

Recruiting

• Conditions: Surgery; Liver Diseases

• Registration Number: NCT06353672
• Lead Sponsor: Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2024-03-26
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postoperative unplanned reoperation	with in 90 days after surgery	The unplanned reoperation due to postoperative complications
Unplanned readmission	with in 90 days after surgery	The unplanned readmission after discharge due to postoperative complications
Postoperative complications	with in 90 days after surgery	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.
Postoperative hospital stay	with in 90 days after surgery	The days of hospital stay after operation

Trial Locations

Locations (1)

First Affiliated Hospital, Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China