Novel Robotic Surgical System for Minimally Invasive Surgery

Robotic Surgery Clinical Trial

— K2robo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151835
• Other study ID #: CREC 2021.472
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: Philip WY Chiu, MD
• Phone: +85291252907
• Email: philipchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Robotic Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong	Outside Of US & Canada

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	intraoperative time	Intraoperative Time	30 days
Secondary	Blood Loss	Amount of blood loss in mls	30 days
Secondary	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
Secondary	Analgesic requirement	Total dose of analgesic (Pethidine) used	30 days
Secondary	Length of Hospital Stay	Days after surgery	30 days