Novel Senhance Robotic System in Urologic Surgery: Its Clinical Application and Implication

An observational study to collect data from the participants who received urologic surgeries using the Senhance Robotic system.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Surgery

Detailed Description

This is an observational study and investigators will collect peri-operative demographic data, and short-term outcomes (3-6 months) from the participants who received minimal invasive surgeries using Senhance robotic system in the National Taiwan University Hospital Yunlin Branch, Urology Department. The investigators want to demonstrate if the robotic system is safe and feasible in urologic laparoscopic surgeries.

The operation included TEP, radical prostatectomy, radical nephrectomy (nephroureterectomy) , adrenalectomy, radical cystectomy, and ureter surgery et al.

up to 2022/12, we had recruited 127 TEP, 83 radical prostatectomies, 17 adrenalectomies, 40 nephrectomies, 29 partial nephrectomies, 13 radical cystectomies and 18 other surgeries, such as ureter surgery

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• Taiwan
  • Outside U.S./Canada
    • Taipei, Outside U.S./Canada, Taiwan
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study populations consisted of aged from 18 years old to 90 years old and had will to receive laparoscopic surgeries using the Senhance robotic system.

The were excluded if there's major severe cardio-pulmonary condition or had received extensive abdominal surgeries.

Description

Patients undergo laparoscopic urologic surgeries

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-operative complications	Using Clavien-Dindo classification to record the safety outcome	postoperative 30 days
short-term outcome	the short-term outcome was according to a different surgery, such as post-operative 3 months PSA, incontinence rate in radical prostatectomy,	3-6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: LunHsiang Yuan, MD, National Taiwan University Hospital Yunlin Branch

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Urology; Senhance; Robotic surgical system
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases
• Other Study ID Numbers: 202004072RINA