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
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
Treatments tested in this trial
- Remote Liver Surgery
- Local Liver Surgery
Treatment groups
148 Participants
are divided into 2 treatment groupsSponsors and collaborators
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