An observational study in Inguinal Hernia, sponsored by Milton Keynes University Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Milton Keynes University Hospital NHS Foundation Trust · Observational
This trial will compare laparoscopic and robotic-assisted inguinal 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 inguinal hernias. The study will randomise 60 patients who require repair of an inguinal 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. The randomisation will occur on a 2:1 basis, with 2 patients allocated to the robotic arm for every 1 patient allocated to the laparoscopic arm. Laparoscopic surgery is already a well-established technique, and therefore the study team believe more valuable data about the outcomes of robotic surgery will be obtained with this randomisation ratio given that no prior studies have been undertaken using this robotic platform. All surgeons in the study will be required to have been involved in at least 20 cases performed using the relevant modality, whether for the robotic or laparoscopic cohorts.
Data will be collected at four key timepoints; recruitment, intraoperatively, at discharge and again at 14 days following intervention. Feasibility outcomes will include willingness to be recruited to study (acceptability), willingness for patient to undergo desired randomised operative approach (acceptability/concordance), withdrawal of patients (non-concordance), study retention (retention rates), and the usefulness and limitations of outcome measures.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 327 observational studies indexed under Hernia.
Browse Hernia studies →Milton Keynes University Hospital NHS Foundation Trust is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who require surgery to repair an inguinal hernia will be approached to participate in the trial.
In this trial, all patients will be only be considered if deemed suitable for surgery via a minimally invasive approach
Exclusion Criteria:
This cohort of participants will have their procedure completed by a human surgeon
Procedure: Procedure/Surgery: Laparoscopic
This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.
Procedure: Robotic
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.
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 questionnaires post operatively at recruitment Day 1 and on day 14. Total scores used not sub scales to be reported.
Time frame: Assessed on Day 1 and Day 14
Satisfaction with life
Quality of life units completion of MFSI-SF questionnaires post operatively at recruitment Day 1 and on day 14. Total scores used not sub scales to be reported.
Time frame: Assessed on Day 1 and 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: Through study completion, an average of 1 year
Pain Scores
Using a uni-dimensional pain score measurement examining the change from baseline.
Time frame: Day 14
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Milton Keynes University Hospital NHS Foundation Trust