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Clinical Trials/NCT05151835
NCT05151835
Recruiting
Not Applicable

A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study

Chinese University of Hong Kong1 site in 1 country20 target enrollmentAugust 24, 2022
ConditionsRobotic Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Robotic Surgery
Sponsor
Chinese University of Hong Kong
Enrollment
20
Locations
1
Primary Endpoint
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Detailed Description

This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.

Registry
clinicaltrials.gov
Start Date
August 24, 2022
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philip Wai Yan CHIU

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • Body mass index \<35 kg/m2
  • Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
  • Willingness to participate as demonstrated by giving informed consent

Exclusion Criteria

  • Contraindication to general anesthesia
  • Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
  • Untreated active infection
  • Noncorrectable coagulopathy
  • Presence of another malignancy or distant metastasis
  • Emergency surgery
  • Vulnerable population (e.g. mentally disabled, pregnancy)

Outcomes

Primary Outcomes

Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System

Time Frame: 30 days

Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure.

Secondary Outcomes

  • intraoperative time(30 days)
  • Blood Loss(30 days)
  • Length of Hospital Stay(30 days)
  • Rate of perioperative complications(30 days)
  • Analgesic requirement(30 days)
  • Pain scores on a visual analog scale(30 days)

Study Sites (1)

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