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Clinical Trials/NCT06353672
NCT06353672
Recruiting
Not Applicable

A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

Zhejiang University1 site in 1 country1,000 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Diseases
Sponsor
Zhejiang University
Enrollment
1000
Locations
1
Primary Endpoint
Postoperative unplanned reoperation
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

TingBo Liang

Professor

Zhejiang University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Postoperative unplanned reoperation

Time Frame: with in 90 days after surgery

The unplanned reoperation due to postoperative complications

Unplanned readmission

Time Frame: with in 90 days after surgery

The unplanned readmission after discharge due to postoperative complications

Postoperative complications

Time Frame: 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

Time Frame: with in 90 days after surgery

The days of hospital stay after operation

Study Sites (1)

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