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

Launched by THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY · Feb 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical robot system called "MicroHand S" that allows doctors to perform surgeries for urinary system conditions from a distance. This means that even if patients live far away from the hospital, a skilled surgeon can operate the robot to perform surgeries for various issues like kidney tumors, bladder cancer, and other urological diseases without needing to be in the same room. The trial aims to find out how effective and safe this robot system is in performing these surgeries remotely.

To participate in the trial, patients must be between 18 and 80 years old and have specific urological conditions that require surgery. They should also be generally healthy, without severe heart or kidney problems. If chosen, participants can expect to receive their surgery using the robot system, which will be monitored closely for success and safety. The trial will include around 100 patients, and the results will help determine if this technology is a good option for treating urological diseases in the future.

Gender

ALL

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