Using a Chinese surgical robot for urological telesurgery

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

This study is testing a new Chinese surgical robot to see if it can safely and effectively help doctors perform remote surgeries on patients with urological tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (other)
• Drugs / interventions: cart
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT05739812 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of the domestically produced 'MicroHand S' surgical robot system for performing telesurgery on patients with various urological tumors. The trial involves a single-arm design where surgeons operate the robot remotely, utilizing advanced network technology to control surgical instruments. Patients will be screened based on specific inclusion and exclusion criteria, and the trial aims to enroll 100 subjects to explore the robot's capabilities across different urological conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with specific urological conditions requiring surgical intervention.

Not a fit: Patients with conditions not suitable for telesurgery or those outside the specified age and health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance surgical precision and patient outcomes in urological procedures.

How similar studies have performed: While telesurgery is an emerging field, previous studies have shown promising results with robotic-assisted surgeries, indicating potential for success in this novel application.

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

Where this trial is running

Qingdao, Shandong

• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Haitao Niu, MD

Conditions: Renal Cell Carcinoma, Adrenal Tumor, Nonfunctioning Kidney, Renal Pelvis Carcinoma, Ureteral Tumor, Bladder Cancer, Prostate Cancer, Pelvic Tumor