Trial Title:
The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery
NCT ID:
NCT05739812
Condition:
Renal Cell Carcinoma
Adrenal Tumor
Nonfunctioning Kidney
Renal Pelvis Carcinoma
Ureteral Tumor
Bladder Cancer
Prostate Cancer
Pelvic Tumor
Renal Cyst
Duplex Kidney
Renal Calculi
Ureteral Calculi
Ureteropelvic Junction Obstruction
Penile Cancer
Conditions: Official terms:
Carcinoma
Penile Neoplasms
Kidney Calculi
Ureteral Calculi
Ureterolithiasis
Calculi
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
telesurgery by domestic surgical robot
Description:
telesurgery of urological diseases by domestic surgical robot
Arm group label:
Urological disease group
Summary:
A single-arm clinical trial was designed in this study. The surgeon will perform
urological telesurgery for patients using Chinese domestically produced "MicroHand S"
surgical robot system. The "MicroHand S" surgical robot system consists of two physically
separated subsystems named the "surgeon console" and the "patient side cart". The surgeon
console includes a stereo image viewer, two master manipulators, a control panel and
several foot pedals. The patient side cart includes a passive arm that can slide in the
up-down direction and be adjusted forward and backward, a swivel head that can rotate
around the vertical axis, and three slave arms. In addition, surgical instruments and
sterile bags are the essential accessories for the "patient side cart". The principle of
the telesurgery is as follows: the surgeon console takes the surgeon's input and
translates manipulation into a control signal. After network transmission, the signals
will be received by the patient side cart and will be used to control the slave robot to
manipulate the instruments to perform the operation within the patient's cavity. The 3D
images captured by the endoscopic camera will be simultaneously sent back to the screen
of the surgeon console as visual feedback. Data between the surgeon console and the
patient side cart will be transmitted through a 5G network or other advanced network
networking scheme. The surgeon remotely manipulates the slave arms and performs surgeries
for patients in remote areas. The safety and efficacy of the robot system in remote
clinical treatment will be verified by the primary and the secondary evaluation criteria.
One hundred patients with urological diseases will be enrolled in the clinical trial.
Primary evaluation criterion:
The success rate of the surgery. Surgery success is defined as that all surgeries are
performed remotely and safely without transfering to other types of surgery, such as open
surgery or normal robot-assisted surgery.
Secondary evaluation criteria:
Operative time, blood loss, postoperative pain, preoperative adjusting time,
hospitalization time, average network latency, task load, peer recognition, anxiety
index.
Patient enrollment:
This experiment aims to investigate the safety and effectiveness of the domestic robot
system in clinical urological surgery under the current network networking scheme. It is
planned that 100 patients with urinary system diseases will participate in the clinical
trial.
Detailed description:
Objective: This clinical trial aims to evaluate the efficacy and safety of telesurgery
for patients with urological tumors using Chinese independently developed "MicroHand S"
Surgical Robot System under the current advanced network networking scheme.
Content: A single-arm clinical trial was designed in this study. The product is
domestically produced "MicroHand S" surgical robot system (Shandong Weigao Surgical Robot
Co., Ltd, China). The patients will be fully informed and the written informed consent
will be signed before the clinical study, According to the inclusion criteria and
exclusion criteria, the researchers will conduct a detailed screening to determine
whether the patients are suitable for the clinical study. Telesurgery will be conducted
for patients who meet the inclusion criteria using the "MicroHand S" surgical robot
system. Data between the "surgeon console" and the "patient side cart" will be
transmitted through the current advanced network networking scheme. Fifty telesurgeries
has been performed for patients with renal tumor, adrenal tumor, or nonfunctional kidney
disease in 2021. All the surgeries were completed successfully, which made an positive
social influence. In order to explore other indications, 100 subjects will be enrolled in
the clinical trial. All diseases will be included if it is applicable to be treated by
telesurgery, such as, adrenal tumor, renal tumor, renal cyst, duplex kidney, renal
calculi, ureteral calculi, ureteropelvic junction obstruction (UPJO), nonfunctional
kidney, renal pelvis tumor, ureteral tumor, bladder cancer, prostate cancer, pelvic
tumor, penile cancer, etc. The safety and efficacy of remote clinical treatment using the
domestic robot system will be verified according to the primary evaluation criterion,
secondary evaluation criteria, and safety evaluation index.
Network connection plan: Two network connection plans were designed in advance to
transmit data between the two sites (the master and the slave) in telesurgery. Plan A:
Both signals (the control signals and the video signals) were transmitted in a VPN
encryption mode under 5G wireless network or other advanced network networking scheme.
Plan B: Both signals were transmitted through the dedicated line. When 5G network or
other advanced network networking scheme was unstable and the surgery was affected, Plan
A could be switched to Plan B to ensure the success of telesurgery. The two sites were
also connected through a video conference system for real time communication and
coordination.
Primary evaluation criterion: The primary evaluation criterion is the success rate of the
surgery.
Secondary evaluation criteria: Secondary evaluation criteria include operative time,
intraoperative blood loss, assembly time, postoperative pain, hospital stay, time to
first flatus, average network latency, task load index, patient acceptance of
telesurgery, peer surgeon acceptance of telesurgery, patient anxiety index, surgeon
anxiety index.
Safety evaluation index: (1) Organ and vascular injury events related to the robot,
including the following injury events: a. Whether there is adjacent organ injury caused
by the robot functional failure during the operation, including liver, spleen and
intestinal injury; b. Whether there is hemorrhoea caused by vascular injury caused by the
robot functional failure during the operation. (2) Adverse events during the study. (3)
Instrument malfunction. a. The communication between the "surgeon console" and the
"patient side cart" is strongly disturbed, the slave arms fail to move and malfunction
cannot be eliminated after reset and restart. b. by surgical instruments cannot be
loosened after the tissue is clamped. c. An alarm sounds when install the instruments. d.
Instruments lose efficacy or they are damaged. (4) Vital signs (body temperature, blood
pressure, and heart rate). (5) Laboratory examination: blood routine, liver and kidney
function, electrolyte.
Researcher selection: In order to strictly ensure the homogeneity and uniformity of
researchers, operators are required to have certain qualifications. All surgeons must
have at least 5 years of experience in laparoscopic general surgery and at least 1-year
experience in robotic surgery. The surgeon will be trained in delay simulation training
before the trial. Meanwhile, product training is also required before the trial, and each
surgeon must complete at least 20 surgeries with the tested robot. All the trainings
above are to help surgeons cross the learning curve.
Background: With the combination of robotic and network communication technology,
telesurgery has become a reality. On the one hand, telesurgery can conserve and optimize
medical resources, providing high-quality medical services to unbalanced areas, such as
rural areas, stricken areas and battlefields. On the other hand, telesurgery can reduce
the time spent by patients waiting for treatment and thus prevent diseases from
worsening. In recent years, the rapid advancements of the fifth and sixth generation
network communication technologies and surgical robotic devices have again boosted the
development of telesurgery since the Lindbergh operation and the research of Anvari et
al. Especially in a country as vast as China, where the difference of the level of
medical care between developed cities and rural areas is huge and the need for
telesurgery is enormous. The demand for telemedicine has also risen significantly,
particularly since the outbreak of COVID-19. However, as the most challenging components
of telemedicine, telesurgery has still developed slowly, and most studies of it are
limited to single-center experiences and as such have some inherent limitations. Based on
this background, we have successfully conducted preliminary studies in which we verified
the safety and feasibility of multiple network plans for telesurgery such as 5G network
slicing technology and heterogeneous multilink network converged transmission technology.
In 2021, our research group carried out a multicenter prospective study evaluating
efficacy and safety of telesurgery for upper urological tumors using the "Micro Hand S"
system robot and a 5G network in Shandong Province, China.
With the prevalence of telesurgery, indications should not limited in upper urological
diseases. More indications should be explored. On such basis, this clinical trial was
designed and performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged 18-80 years.
- BMI was 18-30 kg/m2.
- The American Society of Anesthesiologists (ASA) classification was I, II, or III.
- Patients with adrenal tumor that need radical or partial adrenalectomy
(nonfunctioning adenoma, < 5cm in diameter).
- Patients with renal cell carcinoma that need radical nephrectomy or partial
nephrectomy.
- Patients with renal cyst that need decompression surgery.
- Patients with duplex kidney that need radical nephroureterectomy.
- Patients with renal calculi that need intrasinusal pyelolithotomy.
- Patients with ureteral calculi that need ureterolithotomy.
- Patients with ureteropelvic junction obstruction (UPJO) that need pyeloplasty.
- Patients with urological diseases (such as, pelvic segment disease of the ureter, or
duplex kidney) that need ureteral reimplantation.
- Patients with nonfunctioning kidney that need radical nephrectomy.
- Patients with renal pelvis carcinoma that need radical nephroureterectomy.
- Patients with ureteral tumor that need radical nephroureterectomy.
- Patients with bladder cancer that need radical or partial cystectomy.
- Patients with prostate cancer that need radical prostectomy.
- Patients with penile cancer that need Ilioinguinal lymph node dissection.
Exclusion Criteria:
- Women in pregnancy or lactation
- A history of epilepsy or mental illness
- Previous relevant operation history (all abdominal operations that may increase
difficulty in telesurgery)
- 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)
- Patients with general hemorrhagic diseases and coagulation dysfunction (prothrombin
activity, PTA <25%)
- Patients with active hepatitis and AIDS
- Patients with uncorrected diabetes (random blood glucose, RBG >11.1 mmol/L) and
hypertension (≥160/100 mmHg)
- Patients with severe allergic constitution and suspected or confirmed alcohol,
medicine or drug addiction
- Patients with abdominal infection, peritonitis or diaphragmatic hernia
- Patients with severe systemic infection or metastatic disease
- Patients who are unable to voluntarily participate and sign informed consent
- Other circumstances under which the investigator considers it is inappropriate to
participate in this clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266003
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Niu, PhD
Phone:
18661803117
Email:
niuht0532@126.com
Start date:
February 5, 2023
Completion date:
April 2024
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05739812
