Robot assisted total hysterectomy Surgery
Conditions
Interventions
A prospective single arm cohort study for robot assisted total hysterectomies, with the Versius Surgical Robotic System. Use of Versius, patient care and all follow-ups (up to day 42 +/-2 days) will b
Sponsors
CMR Surgical (United Kingdom)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patient deemed suitable for total laparoscopic hysterectomy 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. Female, aged 18 years or above 4. Female of childbearing potential, must not be pregnant 5. Patients with BMI =40 kg/m². Ideally 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. Uncontrolled hypertension (=/>Systolic: 180 mmHg/Diastolic: 120 mmHg) 4. Diabetes mellitus (Glycemia >11mmol/L; >200 mg/dL) 5. Oncological cases, patients undergoing surgery or treatment for malignant disease 6. Patients who fall into American Society of Anaesthesiologists (ASA) Class IV or above 7. Uterus size of >14 weeks 8. History of chronic alcohol or drug abuse 9. Chronic renal failure or on dialysis 10. Significant medical history or immunocompromised 11. Subjects with any other clinically significant unstable medical disorder, lifethreatening disease, or anything else in the opinion of the Investigator which would contra-indicate a surgical procedure 12. Patient tested COVID positive within last 30 days of screening 13. Patient tested COVID positive within 48 hours within procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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 | — |
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 patient’s medical records 4. Any intra-operative complications during surgery collected as procedural data and from patient’s medical records 5. Return to 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. Vaginal vault healing, as assessed and recoded by surgeon on medical records at the clinic on 42 days post operative follow up 11. Histopathology results of any surgically removed specimens from medical records available at day of discharge and at 30 day follow up 12. 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 13. All adverse events, including postoperative complications reported using Clavien-Dindo Classification and according to medical records, up to 30 days' follow up 14. Device performance data including unplanned instrument usage, clashes, collision detection, alarms, collected as procedural data during surgery | — |
Countries
India
Outcome results
None listed