Robotic Surgery
Conditions
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.
Interventions
DEVICEK2 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| intraoperative time | 30 days | Intraoperative Time |
| Blood Loss | 30 days | Amount of blood loss in mls |
| 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 |
| Length of Hospital Stay | 30 days | Days after surgery |
| 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) |
Countries
China
Contacts
Primary ContactPhilip WY Chiu, MD
Backup ContactMan Yee YUNG, RN
Outcome results
None listed