Status:
COMPLETED
Robotic Cholecystectomy Using the Chinese Micro Hand S Robot: A Controlled, Randomized, Prospective Clinical Study
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Cholecystitis; Gallstone
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
A single-blinded, prospective randomized parallel controlled clinical trial was designed and conducted from December 2019 to November 2020. 82 patients with a gallstone, gallbladder polyp and other be...
Detailed Description
Objective: To determine whether the newly developed Chinese Micro Hand S surgical robot results in non-inferiority outcomes in cholecystectomy compared with the prevalent da Vinci robot. Design: A si...
Eligibility Criteria
Inclusion
- from 18 to 65 years old;
- patients with acute or chronic cholecystitis, gallstone, gallbladder polyp and other benign gallbladder diseases;
- BMI was 18-30 kg/m2;
- the American Society of Anesthesiologists (ASA) classification was I, II, or III.
Exclusion
- women in pregnancy or lactation;
- A history of epilepsy or mental illness;
- Previous relevant operation history;
- Patients with a severe cardiovascular and cerebrovascular disease with New York Heart Association (NYHA) classification III-IV and pulmonary insufficiency who cannot tolerate the operation;
- Liver cirrhosis, kidney failure and other severe liver and kidney dysfunction (ALT and AST exceeded 3 times of the upper limit of normal value, Cr exceeded 1.5 times of the upper limit of normal value).
Key Trial Info
Start Date :
December 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04803487
Start Date
December 3 2019
End Date
December 3 2020
Last Update
March 18 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003