This trial will compare laparoscopic and robotic-assisted abdominal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.
This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of abdominal hernias. The study will randomise 60 patients who require repair of an abdominal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery.
Study Type
OBSERVATIONAL
Surgeon
Versius system
To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score
Time frame: Length of the procedure expected to be between 1-4 hours
Measurement of the rate of participant recruitment
Measure the number of participants recruited over the length of time. The units of measurement will be presented on a scale of number of participants over a predetermined length of time.
Time frame: Through study completion, an average of 1 year.
Measurement of drop-out (withdrawal) rate of participants
Measure the number of participants who withdrawal (drop out) from the trial. The units of measurement will be presented on a scale of numbers of withdrawals versus time.
Time frame: Assessed from Day 1 (Randomisation) to date of withdrawal
Measurement of the unblinding rate of participants
Measure the number of participants where the treatment is unblinded during the trial. This is measured by the number of participants over the length of time who's treatment is unblinded.
Time frame: Through study completion, an average of 1 year.
Mental strain of surgeon
To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score.
Time frame: 30 minutes maximum completion time per surgeon
Health Economics
Explore health economic aspects of each approach via calculation of the entire hospital episode and individual operation (including fixed costs and instrument costs) comparing the cost for cohort using the Versus Surgical Robot versus the human surgeon.
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Time frame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
Communication
To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.
Time frame: 1-4 hours expected for the duration of the procedure
Satisfaction with life scale
Quality of life units completion of EQ-5D-5L questionnaire post operatively on day 14. Total scores used not sub scales to be reported.
Time frame: Assessed on Day 14
Satisfaction with life scale
Quality of life units completion of MFSI-SF questionnaires post operatively on day 14. Total scores used not sub scales to be reported.
Time frame: Assessed on Day 14
Length of in-patient stay
Measure of the time in days of each participant's hospital stay as an in-patient.
Time frame: Up to 4 weeks
Pain Scores
Using a uni-dimensional pain score measurement examining the change from baseline.
Time frame: Days 1, 2, 3, 14 and 28