The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, Poland
RECRUITINGSuccess rate
Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.
Time frame: Day of surgery
Serious Adverse Event rate
Rate of total serious adverse events
Time frame: Up to 30 days post procedure
Operative time
Surgical time from skin incision to skin closure
Time frame: Day of surgery
Estimated blood loss
Amount of blood estimated to be lost during surgery (in mL)
Time frame: Day of surgery
Intra-operative complications
Complications that occur during surgery
Time frame: Day of surgery
Blood transfusions
Need for blood transfusion during or after surgery as well as amount transfused
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
Unplanned instrument use
Whether unplanned use of non-Versius laparoscopic instruments during surgery occurs as well as at what surgical step
Time frame: Day of surgery
Device deficiencies
Any device deficiencies of Versius during surgery
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Time frame: Day of surgery
Reoperation within 24 hours
Need for reoperation after initial surgery
Time frame: 24 hours post-surgery
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
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
Vaginal vault healing
Vaginal vault healing as anticipated for patients that had total laparoscopic hysterectomy
Time frame: 42 days post-surgery