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

NCT05739812 | Unknown

• 1 other identifier: SDWG-NST600S-YCSS-5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• success rate of the telesurgery

  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.

  after the study is completed, up to 2 years.

Secondary Outcomes (11)

• Operative time

  after each procedure is completed, all data will be collected within 4 months

• Intraoperative blood loss

  after each procedure is completed, all data will be collected within 4 months

• Postoperative pain

  at 24±2 hours after each procedure is completed, all data will be collected within 4 months

• Assembly time

  from the time the robot starts to the time the trocar is connected to the robot arm during each procedure, all data will be collected within 4 months

• Hospital stay

  from admission to discharge for each patients, all data will be collected within 4 months

Study Arms (1)

Urological disease group

EXPERIMENTAL

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.

Device: telesurgery by domestic surgical robot

Interventions

telesurgery by domestic surgical robot DEVICE

telesurgery of urological diseases by domestic surgical robot

Urological disease group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

RECRUITING

Related Publications (7)

• Chen H, Pan X, Yang J, Fan J, Qin M, Sun H, Liu J, Li N, Ting DSW, Chen Y. Application of 5G Technology to Conduct Real-Time Teleretinal Laser Photocoagulation for the Treatment of Diabetic Retinopathy. JAMA Ophthalmol. 2021 Sep 1;139(9):975-982. doi: 10.1001/jamaophthalmol.2021.2312.

  PMID: 34236391 BACKGROUND

• Tian W, Fan M, Zeng C, Liu Y, He D, Zhang Q. Telerobotic Spinal Surgery Based on 5G Network: The First 12 Cases. Neurospine. 2020 Mar;17(1):114-120. doi: 10.14245/ns.1938454.227. Epub 2020 Mar 31.

  PMID: 32252160 BACKGROUND

• Nguan C, Miller B, Patel R, Luke PP, Schlachta CM. Pre-clinical remote telesurgery trial of a da Vinci telesurgery prototype. Int J Med Robot. 2008 Dec;4(4):304-9. doi: 10.1002/rcs.210.

  PMID: 18803341 BACKGROUND

• Sterbis JR, Hanly EJ, Herman BC, Marohn MR, Broderick TJ, Shih SP, Harnett B, Doarn C, Schenkman NS. Transcontinental telesurgical nephrectomy using the da Vinci robot in a porcine model. Urology. 2008 May;71(5):971-3. doi: 10.1016/j.urology.2007.11.027. Epub 2008 Mar 4.

  PMID: 18295861 BACKGROUND

• Marescaux J, Leroy J, Rubino F, Smith M, Vix M, Simone M, Mutter D. Transcontinental robot-assisted remote telesurgery: feasibility and potential applications. Ann Surg. 2002 Apr;235(4):487-92. doi: 10.1097/00000658-200204000-00005.

  PMID: 11923603 BACKGROUND

• Yi B, Wang G, Li J, Jiang J, Son Z, Su H, Zhu S, Wang S. Domestically produced Chinese minimally invasive surgical robot system "Micro Hand S" is applied to clinical surgery preliminarily in China. Surg Endosc. 2017 Jan;31(1):487-493. doi: 10.1007/s00464-016-4945-3. Epub 2016 May 18.

  PMID: 27194259 BACKGROUND

• Yao Y, Liu Y, Li Z, Yi B, Wang G, Zhu S. Chinese surgical robot micro hand S: A consecutive case series in general surgery. Int J Surg. 2020 Mar;75:55-59. doi: 10.1016/j.ijsu.2020.01.013. Epub 2020 Jan 23.

  PMID: 31982634 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell; Adrenal Gland Neoplasms; Ureteral Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Pelvic Neoplasms; Kidney Calculi; Ureteral Calculi; Multicystic renal dysplasia, bilateral; Penile Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Ureteral Diseases; Urinary Bladder Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Nephrolithiasis; Urolithiasis; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Penile Diseases

Study Officials

• Haitao Niu, PhD

  The Affiliated Hospital of Qingdao University

  STUDY CHAIR

Central Study Contacts

Haitao Niu, MD

CONTACT

18661803117; niuht0532@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Haitao Niu (the department of Urology)

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 22, 2023
• Study Start: February 5, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)