Novel Robotic Surgical System for Minimally Invasive Surgery

Not Applicable

Recruiting

• Conditions: Robotic Surgery
• Interventions: Device: K2 Robotic Surgical System

• Registration Number: NCT05151835
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2021-11-05
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-12-09
• Study Start: 2022-08-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Surgery	K2 Robotic Surgical System	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.

Primary Outcome Measures

Name	Time	Method
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System	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 Outcome Measures

Name	Time	Method
intraoperative time	30 days	Intraoperative Time
Blood Loss	30 days	Amount of blood loss in mls
Length of Hospital Stay	30 days	Days after surgery
Rate of perioperative complications	30 days	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
Analgesic requirement	30 days	Total dose of analgesic (Pethidine) used
Pain scores on a visual analog scale	30 days	Pain score in visual analog scale scoring system (minimum 0 and maxium 10, higher score represents more pain)

Trial Locations

Locations (1)

Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong; 🇨🇳 Hong Kong, Outside Of US & Canada, China