Robot-assisted cholecystectomy Surgery
Conditions
Interventions
A prospective single-arm cohort study for robot-assisted laparoscopic cholecystectomy with the Versius Surgical Robotic System. Use of Versius, patient care and all follow-ups will be as per standard
Sponsors
CMR Surgical (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient deemed suitable for laparoscopic cholecystectomy procedure using Versius Surgical Robotic System 2. Patients able to provide written informed consent to participate in the study (with help of appropriate legal representatives if required) 3. Male or female, aged 18 years or above 4. Females of childbearing potential must not be pregnant and agree to not become pregnant for the duration of the study 5. Patients with BMI <40 kg/m². Priority BMI 25 to 40 kg/m²
Exclusion criteria
Exclusion criteria: 1. Patient participation in an investigational clinical study within 30 days before screening 2. Inability or difficulties to provide informed consent 3. Oncological cases: patients undergoing surgery or treatment for malignant disease 4. Patients who fall into the American Society of Anaesthesiologists (ASA) Class IV or above 5. History of chronic alcohol or drug abuse 6. Chronic renal failure or on dialysis 7. Significant medical history or immunocompromised 8. Subjects with any other clinically significant unstable medical disorder, life-threatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure 9. Patient tested COVID positive within the last 30 days of screening 10. Patient tested COVID positive within 48 hours of the procedure 11. Diabetes mellitus (Glycemia >11mmol/l; >200 mg/dl) 12. Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy outcome: Rate of successful completion of robot assisted surgery without unplanned conversion to other laparoscopic or open surgery, as recorded on the data entry platform Primary safety outcome: Incidence of serious adverse events, recorded on the data entry platform at any time between commencement of surgery (intraoperative) to the end of the trial (postoperative, between incidence of surgery to 30 days after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operative time measured in minutes from incision to skin closure at the facility, collected as procedural data from medical records 2. Estimated blood loss (in ml) during surgery, collected as procedural data from medical records 3. Blood transfusion during surgery (number of blood transfusion products used [if any]) collected from the patient’s medical records 4. Any intra-operative complications during surgery collected as procedural data and from the patient’s medical records 5. Return to the operating room within 24 hours after surgery, measured using medical records 6. Length of hospital stay in days (from date of procedure to date of discharge), measured using medical records 7. Incidence of readmission to hospital within 30 days after surgery, measured using medical records and at 30-day follow-up 8. Incidence of reoperation within 30 days after surgery, measured using medical records and at 30-day follow-up 9. 30-day mortality from medical records and/or follow-up visit/call during the 30-day follow up 10. Histopathology results of any surgically removed specimens from medical records available at the day of discharge and at 30 days follow up 11. Incidence of device deficiencies and use errors regardless of relationship to an adverse event, collected as procedural and/or adverse event data and from patient medical records, from intraoperative period until discharge 12. All adverse events, including postoperative complications reported using Clavien-Dindo Classification and according to medical records, up to 30 days' follow up 13. Device performance data including unplanned instrument usage, clashes, collision detection, alarms, collected as procedural data during surgery | — |
Countries
Poland
Outcome results
None listed