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

June 24, 2024 updated by: National Taiwan University Hospital

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

Study Overview

Status

Completed

Conditions

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-operative complications Time Frame: postoperative 30 days	Using Clavien-Dindo classification to record the safety outcome	postoperative 30 days
short-term outcome Time Frame: 3-6 months	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

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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