Versius Robotic Surgery in the NHS: A Multi-Specialty Retrospective Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCMR Surgical Ltd

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Versius Robotic-Assisted Surgery
Group B: Non-Versius Surgical Cohort

Trial outcomes

Primary outcomes

1

Procedure related complication rates

Rate of total procedure related complications within 30 days and up to 12 months following surgery

Time frame
Within 30 days and 12 months after surgery

Secondary outcomes

1

Length of hospital stay

Hospital stay in days from day of surgery until discharge

Time frame
Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days
2

Conversion rate

Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery.

Time frame
Up to completion of surgery
3

Operative time

Surgical time from skin incision to skin closure

Time frame
Up to completion of surgery
4

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.

Time frame
Within 12 months following surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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