Clinical trial NCT05151835: Novel Robotic Surgical System for Minimally Invasive Surgery
Official title: A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Robotic Surgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System
timeFrame: 30 days
Secondary outcomes:
measure: Rate of perioperative complications
timeFrame: 30 days
measure: intraoperative time
timeFrame: 30 days
measure: Blood Loss
timeFrame: 30 days
measure: Pain scores on a visual analog scale
timeFrame: 30 days
measure: Analgesic requirement
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
state: Outside Of US & Canada
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon SM Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: