Robotic-assisted Soft-tissue Surgery
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
CMR Surgical Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing one of the index procedures with Versius, laparoscopically or with open surgery. 2. Patients who provide written consent (16 years or older) or for whom an appropriate legal representative who provides written informed consent (\<16 years old).
Exclusion criteria
1. Patients participating in an interventional clinical study that might impact the defined endpoints. 2. Patients undergoing concomitant surgery. 3. Patients or appropriate legal representatives unwilling to provide written consent. 4. Patients with BMI at or above 40 kg/m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure related complication rates | Within 30 days and 12 months after surgery | Rate of total procedure related complications within 30 days and up to 12 months following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision surgery rate | Within 12 months following surgery | 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. |
| Rate of pre-defined index procedure specific complications | Within 30 days and 12 months after surgery | Percentage of participants who experience one or more pre-defined procedure-specific complications related to the index surgical procedure |
| Length of hospital stay | 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 | Hospital stay in days from day of surgery until discharge |
| Conversion rate | Up to completion of surgery | Proportion of surgical procedures requiring unplanned conversion to conventional laparoscopic or open surgery. |
| Operative time | Up to completion of surgery | Surgical time from skin incision to skin closure |
Outcome results
None listed