Novel Robotic Surgical System for Minimally Invasive Surgery (K2robo)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Robotic Surgery
• Intervention / Treatment: Device: K2 Robotic Surgical System

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip WY Chiu, MD; Phone Number: +85291252907; Email: philipchiu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Man Yee YUNG, RN; Phone Number: +85235052956; Email: myyung@surgery.cuhk.edu.hk

Study Locations

• China
  • Outside Of US & Canada
    • Hong Kong, Outside Of US & Canada, China, 00000
      • Recruiting
      • Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
      • Contact: Philip WY Chiu, MD; Phone Number: 85235053952; Email: philipchiu@surgery.cuhk.edu.hk
      • Contact: Man Yee Yung; Phone Number: 85235052956; Email: myyung@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Robotic Surgery; Prospective single arm study to investigate effect of a novel robotic surgical system on safety, efficacy and outcomes for performance of minimally invasive surgery across urology, upper and lower GI surgery.

Device: K2 Robotic Surgical System; The K2 Robotic Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in the thorax and abdomen. The K2 Robotic Surgical System consists of a Surgeon Console [SGC], a Patient Side Robot [PSR], and a Vision Cart [VCT], and is used with an endoscope, Surgical Instruments [SGI], and Accessories [ACC]. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides a view of the abdominal cavity and surgical instrumentation, along with icons and other user interface features.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of perioperative complications	intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification	30 days
intraoperative time	Intraoperative Time	30 days
Blood Loss	Amount of blood loss in mls	30 days
Pain scores on a visual analog scale	Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain)	30 days
Analgesic requirement	Total dose of analgesic (Pethidine) used	30 days
Length of Hospital Stay	Days after surgery	30 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Simon SM Ng, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CREC 2021.472

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No