Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Renal Insufficiency

Kidney Calculi

Nephrolithiasis

Calculi

Ureteral Neoplasms

Constriction, Pathologic

Kidney Neoplasms

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Pathological Conditions, Anatomical

Urolithiasis

Urinary Calculi

Urologic Neoplasms

Urogenital Neoplasms

Ureteral Diseases

Tumor part of the kidney or ureter and ureteral stricture is surgically removed or repaired and the kidney is restored and transplanted to a family member recipient

Restored Kidney Transplant Between Family Members

Yoshihide Ogawa, MD, PhD

Makoto Mannami, MD

Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly comeback to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors.

Due to the fact that the number of deceased donors are scarce and only living renal transplantations between the family members or relatives are currently allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation.

There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan.

Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal cancer) of living renal transplantations between family members and relatives with restored donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for our patients who are on dialysis for many years due to the renal failure.

A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members

A Clinical Study of the Living-related Renal Transplantation With Restored Kidneys (Interventional Trial)

Tokushukai Medical Group

Yoshihide Ogawa

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Prostatic Neoplasms

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Pelvic Neoplasms

Cysts

Ureteral Calculi

Ureterolithiasis

Adrenal Gland Neoplasms

Penile Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Penile Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Penile Cancer

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Racepinephrine

Epinephryl borate

Patients with urological diseases (renal cell carcinoma, nonfunctioning kidney and adrenal tumor, renal pelvis carcinoma, ureteral tumor, bladder cancer, prostate cancer, pelvic tumor) will be treated by telesurgery.

telesurgery of urological diseases by domestic surgical robot

telesurgery by domestic surgical robot

Haitao Niu, MD

Haitao Niu, PhD

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.

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.

The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery

The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery, an Exploratory Study

The success of the telesurgery is the robot-assisted telesurgery without transfering to other types of surgery, such as open surgery or normal robot-assisted surgery. The number of the success divided by the total number is the success rate.

The operative time is from the time the robot is assembled till the incision is sutured.

Intraoperative blood loss is the total amount of blood loss from the beginning of the operation (after the robot is assembled) to the incision is sutured. The blood loss is estimated by weight. Estimated blood loss (g) = the weight of the gauze wiping up all the blood - the weight of the dry gauze. And 1g = 1ml.

Postoperative pain is assessed by a visual analog scale (VAS) with a range from 0 point (no pain) to 10 points (maximum pain) at 24±2 hours postoperatively.

The assembly time is from the time the robot starts to the time the trocar is connected to the robot arm.

The hospital stay is the total number of days from the admission to the discharge of patients.

Average network latency is monitored by specific software in real time during the telesurgery.

Task load will be evaluated through NASA-TLX questionnaire filled by the surgeons.

Patient acceptance of telesurgery will be assessed through TPSQ questionnaire filled by the patients 1 day before operation.

Peer surgeon acceptance of telesurgery will be systematic reviewed through TAKA questionnaire filled by peer surgeons.

Patient anxiety index will be assessed through TP-SAS questionnaire filled by patients.

Surgeon anxiety index will be assessed through TP-SAS questionnaire filled by operating surgeons and assistant surgeons.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members	NCT00994188	Kidney Neoplasm Kidney Stone Ureteral Tumor Ureteral Strict... Renal Insuffici...	Restored Kidney...	20 Years -	Tokushukai Medical Group
The Efficacy and Safety of Chinese Domestic Surgical Robot System in Urological Telesurgery	NCT05739812	Renal Cell Carc... Adrenal Tumor Nonfunctioning ... Renal Pelvis Ca... Ureteral Tumor Bladder Cancer Prostate Cancer Pelvic Tumor Renal Cyst Duplex Kidney Renal Calculi Ureteral Calcul... Ureteropelvic J... Penile Cancer	telesurgery by ...	18 Years - 80 Years	The Affiliated Hospital of Qingdao University

Spots Global Cancer Trial Database for ureteral tumor