Novel Robotic Surgical System for Minimally Invasive Surgery
- Conditions
- Robotic Surgery
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
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)
Analgesic requirement 30 days Total dose of analgesic (Pethidine) used
Related Research Topics
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Trial Locations
- Locations (1)
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
🇨🇳Hong Kong, Outside Of US & Canada, China
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong🇨🇳Hong Kong, Outside Of US & Canada, ChinaPhilip WY Chiu, MDContact85235053952philipchiu@surgery.cuhk.edu.hkMan Yee YungContact85235052956myyung@surgery.cuhk.edu.hk