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

NCT04803487 | Completed Early Phase 1

• 1 other identifier: SDWG-NST600S-CT
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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 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

Keywords

Surgical robot; Robot-assisted cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Success rate of the surgery

  the proportion of patients with successful operation in all participating patients in the experimental or control group

  after the study is completed, up to 14 months

Secondary Outcomes (5)

• assembly time

  after the robot is assembled, all data will be collected within 14 months

• operation time

  after the procedure is completed, all data will be collected within 14 months

• blood loss

  after the procedure is completed, all data will be collected within 14 months

• Time to first flatus

  after the intestinal function revival of the patients, all data will be collected within 14 months

• The hospital stay

  from the admission to the discharge, all data will be collected within 14 months

Study Arms (2)

the Micro Hand S robot group

EXPERIMENTAL

41 patients were randomly allocated in the Micro Hand S robot group and cholecystectomy was performed using the Micro Hand S robot.

Other: robot-assisted cholecystectomy

the da Vinci robot group

OTHER

41 patients were randomly allocated in the da Vinci robot group and cholecystectomy was performed using the da Vinci robot.

Other: robot-assisted cholecystectomy

Interventions

robot-assisted cholecystectomy OTHER

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

the Micro Hand S robot group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Related Publications (20)

• Asad U, Wang CF, Jones MW. Laparoscopic Cholecystectomy. 2025 Jul 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448145/

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• Li J, Zhu S, Juan J, Yi B. Preliminary exploration of robotic complete mesocolic excision for colon cancer with the domestically produced Chinese minimally invasive Micro Hand S surgical robot system. Int J Med Robot. 2020 Dec;16(6):1-8. doi: 10.1002/rcs.2148. Epub 2020 Sep 11.

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• Luo D, Liu Y, Zhu H, Li X, Gao W, Li X, Zhu S, Yu X. The MicroHand S robotic-assisted versus Da Vinci robotic-assisted radical resection for patients with sigmoid colon cancer: a single-center retrospective study. Surg Endosc. 2020 Aug;34(8):3368-3374. doi: 10.1007/s00464-019-07107-z. Epub 2019 Sep 3.

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MeSH Terms

Conditions

Cholecystitis; Gallstones

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Weidong Guo, MD

  The Affiliated Hospital of Qingdao University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Haitao Niu (The department of Urology)

Model Details: random controlled trial

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 17, 2021
• Study Start: December 3, 2019
• Primary Completion: November 3, 2020
• Study Completion: December 3, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Case record form of the patients will be shared within six months after the trial complete

Locations

CN (1)