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Robotic Cholecystectomy Using the Chinese Micro Hand S Robot: A Controlled, Randomized, Prospective Clinical Study

NCT04803487 · The Affiliated Hospital of Qingdao University · Updated 18 March 2021

What is being tested
robot-assisted cholecystectomy; robot-assisted cholecystectomy
For
Cholecystitis; Gallstone
Kind of study
Tests a treatment or device on volunteers. Early phase 1.
Who can join
Ages 18 years to 65 years. About 82 people. The full rules are on the registry page.
Where
China
When
Starts or started 3 Dec 2019, ends 3 Dec 2020. Registered 17 March 2021.
Results
None posted yet.

In the researchers' words

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 benign gallbladder diseases were enrolled in this study. Finally, 82 patients were randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Standard robot-assisted transabdominal cholecystectomy was conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative pain, comprehensive complication index, resident time and patient satisfaciton were recorded. The aim of the study is 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.
ClinicalTrials.gov, NCT04803487

Sites

  • The Affiliated Hospital of Qingdao UniversityQingdao, Shandong, China