The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures.
Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan
Milan, Italy
Success rate
Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery
Time frame: Up to completion of surgery
Serious Adverse Event rate
Rate of total procedure related serious adverse events
Time frame: Up to 30 days post procedure
Operative time
Surgical time from skin incision to skin closure
Time frame: Up to completion of surgery
Estimated blood loss
Amount of blood estimated to be lost during surgery (in mL)
Time frame: Up to completion of surgery
Intra-operative adverse events
Adverse events that occur during surgery
Time frame: Up to completion of surgery
Blood transfusion
Need for blood transfusion during surgery as well as amount transfused
Time frame: Up to completion of surgery
Device deficiencies
Any device deficiencies of Versius during surgery
Time frame: Up to completion of surgery
Reoperation within 24 hours
Need for reoperation after initial surgery
Time frame: 24 hours post-surgery
Length of hospital stay
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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
Adverse events
Rate of adverse events
Time frame: Up to 30 days post-surgery
Readmission
Hospital readmission after post-surgical discharge
Time frame: Up to 30 days post-surgery
Reoperation within 30 days
Need for reoperation as a result of interventional surgery itself or the indication for surgery
Time frame: Up to 30 days post-surgery
Mortality rate
Time frame: Up to 30 days post-surgery