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NCT Number: NCT06353672

A Study to Evaluate Safety and Feasibility of Robotic Liver Resection

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital, Medical College of Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Tingbo Liang, MD,PHD

CONTACT

[email protected]

086-571-87236688

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Robotic liver resection

Device

Liver resection using Da Vinci robotic system

Primary outcomes

  1. 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.

  2. Postoperative hospital stay

    Time frame: with in 90 days after surgery

    The days of hospital stay after operation

  3. Postoperative unplanned reoperation

    Time frame: with in 90 days after surgery

    The unplanned reoperation due to postoperative complications

  4. Unplanned readmission

    Time frame: with in 90 days after surgery

    The unplanned readmission after discharge due to postoperative complications

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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