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

NCT04803487 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2021-03-18

No results posted yet for this study

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 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.

Conditions

  • Cholecystitis; Gallstone

Interventions

OTHER

robot-assisted cholecystectomy

cholecystectomy was performed for patients using the Chinese Micro Hand S surgical robot.

OTHER

robot-assisted cholecystectomy

cholecystectomy was performed for patients using the da Vinci surgical robot.

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    lead OTHER

Principal Investigators

  • Weidong Guo, MD · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2020-11-03
Completion
2020-12-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04803487 on ClinicalTrials.gov