About this trial
To generate robust, real-world comparative evidence on the short and long-term clinical outcomes following surgical intervention with Versius Robot-Assisted Surgery versus surgical standard of care across predefined soft-tissue index procedures in routine NHS practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing one of the index procedures with Versius, laparoscopically or with open surgery.
Patients who provide written consent (16 years or older) or for whom an appropriate legal representative who provides written informed consent (<16 years old).
Disqualifiers
Patients participating in an interventional clinical study that might impact the defined endpoints.
Patients undergoing concomitant surgery.
Patients or appropriate legal representatives unwilling to provide written consent.
Patients with BMI at or above 40 kg/m2.
Trial population
Patients undergoing soft-tissue surgical procedures using the Versius Surgical System or a comparator surgical approach (laparoscopic or open surgery).
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Procedure related complication rates
Rate of total procedure related complications within 30 days and up to 12 months following surgery
Secondary outcomes
Length of hospital stay
Hospital stay in days from day of surgery until discharge
Conversion rate
Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery.
Operative time
Surgical time from skin incision to skin closure
Revision surgery rate
Proportion of participants requiring revision surgery within 12 months following the index surgical procedure. Revision surgery is defined as any subsequent surgical procedure required as a result of the index surgical procedure or the underlying condition for which the index surgical procedure was performed.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: