Clinical trial NCT05462392: Robot-assisted Urological Surgeries Using the MicroHand S Robot
Official title: Robot-assisted Urological Surgeries Using the MicroHand S Robot: a Prospective, Single Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Prostate Cancer
Renal Cancer
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

Brief summary: A single-blinded, prospective randomized parallel controlled clinical trial is designed and will be conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six patients (anticipated) with renal cancer or bladder cancer or prostate cancer will be enrolled in this study. Those patients will be enrolled by two hospital centers and the patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group. Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, continence rate (if applicable), postoperative pain, comprehensive complication index, resident time and surgeon satisfaction 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 urological surgeries 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 partial nephrectomy, radical cystectomy, and radical prostatectomy, compared with the prevalent da Vinci robot.

Design: A single-blinded, prospective randomized parallel controlled clinical trial will be conducted from July 2022 to November 2023 (anticipated). One hundred and thirty-six patients (anticipated) with renal cancer or bladder cancer or prostate cancer will be enrolled in this study. Those patients will be enrolled by two hospital centers and the patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical robot group.

Interventions: Robot-assisted urological surgeries, such as partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot.

Main 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 intra- and post-operative complications, comprehensive complication index, assembly time, operation time, intraoperative hemorrhage, postoperative pain, resident time, surgeon satisfaction, incidence of adverse events, instrument malfunction, vital signs, routine blood test, hepatic and liver function.

Background:

Prostate cancer is a common disease of elderly male. With the continuous growth of life expectancy, the change of diet structure and the improvement of diagnostic technology, the incidence rate of prostate cancer has increased in recent years. Radical prostatectomy can be performed for cancer confined within the prostate capsule, which is also the best treatment for prostate cancer. At present, the commonly used surgical methods include traditional open prostatectomy, laparoscopic prostatectomy, and robot-assisted prostatectomy.

Minimally invasive surgery has always been the unremitting pursuit of surgeons. In the past decade, da Vinci robot system has expanded rapidly in China, especially in some fields of Urology, showing great advantages. In July 2000, da Vinci robotic surgery system was approved by FDA for clinical surgery. In July 2001, binder and others completed the world's first da Vinci robotic surgery system assisted laparoscopic radical prostatectomy. Since then, da Vinci robotic surgery has been widely used in clinical surgery worldwide, such as Urology, general surgery, cardiothoracic surgery, obstetrics and Gynecology, pediatric surgery, etc. In recent ten years, da Vinci robotic surgery in China has developed rapidly, and the number of urological surgery cases is increasing rapidly. It is widely used in radical prostatectomy, partial nephrectomy, radical cystectomy, pyeloplasty, adrenalectomy and other urological surgery. This is mainly due to the unique anatomical structure of Urology, which enables da Vinci system to take its advantages such as 3D high-definition vision, precise cutting and separation, intracavitary suture technology, and short learning curve.

The special anatomical position of the prostate and the surrounding anatomical structure determine the difficulty of the operation. In terms of learning curve, it needs 50-100 cases for laparoscopic surgery to pass the learning curve, and it needs 10-20 cases for da Vinci robotic surgery system to pass the learning curve; In terms of visual field, the anatomy of robot assisted surgery is clearer, which is conducive to the protection of urethral membrane and neurovascular bundle, and sexual function, and the "double construction" of anatomy and function. In addition, it also has the characteristics of less bleeding and complications, rapid postoperative recovery, short hospital stay, and can achieve the same or better oncological and functional results.

In nephrectomy or partial nephrectomy, compared with laparoscopic surgery, the learning curve is greatly shortened; By providing high-resolution and three-dimensional images, magnifying the images can make the surgical field clearer; Moreover, the da Vinci robotic surgery system has seven degrees of freedom, which can simulate the movement of the hand, so that the surgeon can better complete the incision, fine suture and reconstruction, zoom action, tremor filtering, which can alleviate the hand fatigue of the surgeon, greatly increase the safety of hand surgery, reduce the time of renal warm ischemia, and maximize the protection of renal function.

In conclusion, when performing radical prostatectomy, radical cystectomy or partial nephrectomy using robot surgery system, it has certain advantages compared with laparoscopic surgery, and it also needs to record its related complications, especially electrical machinery related complications.

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, a total of 136 patients will be included in this study from from July 2022 to November 2023 (anticipated). Those patients will be enrolled by two hospital centers and the patients will be randomly divided into the Micro Hand S surgical robot group and the da Vinci surgical 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. Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. The success rate of operation, assembly time, operation time, intraoperative hemorrhage, continence rate (if applicable), postoperative pain, comprehensive complication index, resident time and surgeon satisfaction were recorded.

Robot-assisted partial nephrectomy, radical cystectomy, and radical prostatectomy will be conducted using the Micro Hand S robot or the da Vinci robot. 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, postoperative complications, and resident time were also recorded. All the patients were followed up by telephone at 30±5 days postoperatively to evaluate the incidence of adverse events.

Eligibility criteria: Inclusion Criteria:

* BMI was 18-30 kg/m2;
* patients that need partial nephrectomy, radical cystectomy, and radical prostatectomy.
* patients that understand the benefits and risks of this test, and are willing to participate and sign the informed consent form

Exclusion Criteria:

* Previous abdominal and pelvic surgery history (preoperative evaluation may affect this operation)
* People with serious uncontrolled diseases or acute infections, including but not limited to: Patients with active tuberculosis and HIV antibody positive; Those who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose copy number of hepatitis B virus DNA (HBV-DNA) is higher than the lower limit of detection or the range of normal values; Hepatitis C virus (HCV) antibody positive; Treponema pallidum positive patients; Covid-19 positive patients
* Long term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs were stopped less than 1 week before operation), and patients with a history of hemorrhagic diseases or hematopoietic dysfunction or coagulation dysfunction; Serious allergic constitution and suspected or confirmed alcohol, drug or drug addiction; Patients with epilepsy or mental history or cognitive impairment
* Patients with cardiovascular and cerebrovascular diseases, blood system diseases, or poor control of blood glucose and blood pressure, who cannot tolerate anesthesia or increase the risk of surgery according to the evaluation of the researcher
* women in pregnancy or lactation
* Patients who have participated or are participating in clinical research of other drugs, biological agents or medical devices in the past 3 months
* Other conditions that the researcher believes are not suitable to participate in this experiment

Primary outcomes:
measure: Success rate of the surgery
timeFrame: after the study is completed, up to 18 months
Secondary outcomes:
measure: assembly time
timeFrame: after the robot is assembled, all data will be collected within 18 months
Other outcomes:
measure: blood loss
timeFrame: after the procedure is completed, all data will be collected within 14 months
measure: The hospital stay
timeFrame: from the admission to the discharge, all data will be collected within 14 months
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: