Robotic Cholecystectomy Using the Chinese Micro Hand S Robot: A Controlled, Randomized, Prospective Clinical Study
Condition: Cholecystitis; Gallstone
MeSH terms: Cholecystitis; Gallstones
Study type: Interventional
Phase: Early Phase 1

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.
    

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 single-blinded, prospective randomized parallel controlled clinical trial was
      designed and conducted from December 2019 to November 2020. The study was conducted in an
      academic hospital. 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.

      Interventions: Standard robot-assisted transabdominal cholecystectomy was conducted using the
      Micro Hand S robot or the da Vinci robot.

      Main outcomes and measures: The main outcome was the success rate of operation. Surgical
      success was defined as that the surgical procedures were completed by the experimental or
      control product without transferring to non-robotic surgery. Secondary outcomes included
      assembly time, operation time, intraoperative hemorrhage, time to first flatus, postoperative
      pain, comprehensive complication index, resident time and patient satisfaction.

      Background:

      Cholecystectomy is one of the most common operations in general surgery, with about half a
      million patients getting cholecystectomy each year in the United States. In the 1990s,
      minimally invasive surgery (MIS), as a new technology, greatly improved the traditional open
      abdominal surgery, of which defects are known as the big wound and long time to recover.
      Today, nearly 90% of cholecystectomy are performed laparoscopically. Previous studies have
      shown that laparoscopic cholecystectomy may reduce postoperative pain, shorten the hospital
      stay, and save the overall cost in hospital, which has become the standard operation for the
      treatment of gallbladder disease. In recent years, robot-assisted laparoscopic surgery has
      become more and more widely used in general surgery because of its advantages of 3D visions,
      high magnification, tremor suppression, and precise manipulation. According to a reported
      retrospective study, the da Vinci robot-assisted cholecystectomy showed excellent operation
      security, which can achieve the same therapeutic effect as the conventional laparoscopic
      cholecystectomy. But studies also reported that the increased cost may be the main problem of
      the da Vinci robot-assisted cholecystectomy.

      The Micro Hand S surgical robot is a new generation of Chinese independently developed
      surgical robot system. Apart from the flexibility and intelligence in operation manipulation,
      the Micro Hand S surgical robot also has the advantages of small size, portable equipment,
      low maintenance costs and outstanding equipment compatibility. After initial preclinical
      trials, the Micro Hand S surgical robot has been successfully applied in clinic, and proved
      security and feasibility in various gastrointestinal surgery.

      Since 2019, investigators in this group have designed and taken up research to assist
      laparoscopic cholecystectomy with the Micro Hand S surgical robot, which is noted as a
      prospective, randomized, single-blind, and parallel controlled clinical trial. The primary
      purpose of this 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.

      Method:

      The study was designed as a single-blind prospective randomized clinical trial since it is
      inevitable for the surgeon to know what kind of robot to use during the operation. After
      obtaining the approval of the Ethics Review Committee and other relevant institutions of the
      Affiliated Hospital of Qingdao University, a total of 82 patients were included in this study
      from December 2019 to November 2020. Finally, 82 patients were randomly divided into the
      Micro Hand S robot group and the da Vinci robot group. All enrolled patients were fully
      informed and signed the informed consent. Patients were randomly assigned to each group in a
      1:1 ratio, and information of the grouping and intervention measures were not available to
      patients. Patients of each group were matched for age, sex, body mass index (BMI), and
      complications to reduce confounding intervention factors.

      Surgical procedure:

      The patient was placed in the supine position after general anesthesia. The Veress needle was
      inserted at 2cm below the umbilicus (point A) to establish the CO2 artificial
      pneumoperitoneum. A 12mm trocar was inserted into the abdominal cavity and the
      pneumoperitoneum tube was connected to the trocar. The intra-abdominal pressure was set at
      11-13mmHg, and then the preheated three-dimensional laparoscope and cold-light source were
      placed into the abdominal cavity through the trocar. Then a thorough examination was taken on
      the intended trocar points and the surgical area. After adjusting the patient with a
      Trendelenburg position inclined to the left, 10.5mm magnetic trocars were respectively placed
      at 2-3cm medial side of the right anterior axillary line, 8-10cm below the costal margin
      (point B); and 2-3cm below the costal margin of the left mid-clavicular line (point C); and
      were connected to the robotic arms No. 1 and 2. Besides, a 10mm trocar were placed at point D
      (lateral inferior of the line connecting point A and C) as the auxiliary channel. The surgeon
      held the neck of the gallbladder or Hartmann's Pouch with bipolar forceps, and pulled the
      neck to the right upper to open the serosal layer of the cystic duct. The cystic duct and the
      cystic artery were then separated by blunt dissection so as to distinguish the common bile
      duct, hepatic common bile duct, and cystic duct. Clamp and cut off the cystic duct near the
      gallbladder's neck with a Hemo-lock clamp. The cystic artery was found medial posterior side
      of the cystic duct. Clamp and cut off the cystic artery with Hemo-lock clamp. Pull the
      gallbladder's neck upward and remove the gallbladder by anterograde resection with an
      ultrasonic knife. The assistant assisted in dragging the gallbladder and the liver bed to
      keep a certain tension. The intact gallbladder was put into the specimen bag and removed.
      Bleeding and bile leakage was carefully checked, and the gallbladder bed was coagulated. The
      operating instruments were withdrawn from the patient's abdominal cavity after checking the
      instruments and the gauze. The pneumoperitoneum was exsufflated and the incisions were
      closed.

      During the operation, the assembly time, intraoperative blood loss, operation time, operation
      success rate, and the adjacent organ and vascular injury caused by the failure of the tested
      system were recorded. Pain score was analyzed 24±2 hours after the surgery. The vital signs
      (temperature, pulse, respiration, blood pressure) were measured on the 3rd day
      postoperatively. Meanwhile, the routine blood test (red blood cells, white blood cells and
      neutrophils, platelet, hemoglobin), liver and renal function (ALT, AST, TP, ALB, GLU, TBIL,
      BUN, and CREA), the electrolyte (K, Na, Cl, Ca), blood sugar, and color ultrasound of liver,
      gallbladder, pancreas and spleen were checked. Operating surgeons filled in the satisfaction
      questionnaire postoperatively. Furthermore, the patients' postoperative condition changes,
      postoperative medication, the first postoperative anal exhaust, postoperative complications,
      and resident time were also recorded. All the patients were followed up by telephone at 30±5
      days postoperatively to evaluate the incidncee of adverse events.
    

Intervention name(s): robot-assisted cholecystectomy; robot-assisted cholecystectomy
Intervention type(s): Other; Other
Intervention description(s): cholecystectomy was performed for patients using the Chinese Micro Hand S surgical robot.; cholecystectomy was performed for patients using the da Vinci surgical robot.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: random controlled trial
Masking: Single (Participant)
Primary purpose: Other
Keywords: Surgical robot; Robot-assisted cholecystectomy