Health TrialsbyHealthPanel

A Study About Remote and Local Liver Surgery

ConditionLiver Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery.

The main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery.

Participants will:

Undergo remote or local robotic liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18-75 years old (inclusive), gender not restricted;

BMI: 18-30 Kg/m2;

Relevant indications for liver surgery;

Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;

Disqualifiers

Patients with severe circulatory system diseases who cannot tolerate surgery;

Pregnant or lactating women;

Patients with a history of epilepsy or mental illness;

Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Remote Liver Surgery

    Device

    The patients in this arm will undergo remote liver surgery.

  • Local Liver Surgery

    Device

    The patients in this arm will undergo local liver surgery.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Local SurgeryActive comparator 1 intervention
Group B: Remote SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Textbook outcome in liver surgery

The textbook outcome in liver surgery is defined as the absence of intraoperative incidents of grade 2 or higher (defined according to the Oslo classification), postoperative bile leak of grade B or C (according to the severity grading of the International Study Group of Liver Surgery),30 severe complications (Clavien-Dindo grade III or higher), postoperative reintervention (ie, surgical, endoscopic, or radiologic), readmission within 30 days after discharge, in-hospital mortality, and the presence of R0 resection margin (ie, 1 mm or more tumor-free margin).

Time frame
6 weeks

Secondary outcomes

1

Surgery Success rate

The number of subjects who successfully completed remote surgical treatment using the experimental equipment, as a proportion of the total number of subjects. The definition of a successful surgery: (a) The surgical process was completed according to the original plan; (b) There was no conversion of surgical methods, such as remote-local, remote-laparoscopic/open; (c) There was no delay due to failure of the surgical system. Whether each case was successful should be confirmed by the medical team after the surgery based on the pre-set criteria for judgment.

Time frame
1 day
2

Overall complication rate

Time frame
6 weeks
3

Operation Time

Time frame
During surgery
4

Console Time

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

The First Medical Center of Chinese PLA General Hospital

Collaborator

The First Affiliated Hospital of Anhui Medical University

Collaborator

First Affiliated Hospital of Guangxi Medical University

Collaborator

The Affiliated Hospital Of Guizhou Medical University

Collaborator

Affiliated Hospital of Qinghai University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

Xinqiao Hospital, Amry Medical University

Collaborator

Wuhan TongJi Hospital

Collaborator

Zhujiang Hospital

Collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborator

First Affiliated Hospital of Chengdu Medical College

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: