Versius Or Laparoscopic TransAbdominal Inguinal Hernia REpair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Procedure/Surgery: Laparoscopic
* Procedure: Robotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Need for inguinal hernia repair surgery Deemed suitable for minimally invasive surgery Exclusion Criteria: Patients who are unable to consent Prisoners Patients in need of emergency surgery Patients with inguinoscrotal or recurrent inguinal hernias

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic Arm<br>This cohort of participants will have their procedure completed by a human surgeon | Procedure: Procedure/Surgery: Laparoscopic<br>* Surgeon<br>|
| Robotic Arm<br>This cohort of participants will have their procedure completed by the Versius Surgical Robotic System. | Procedure: Robotic<br>* Versius system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Length of the procedure expected to be between 1-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion, an average of 1 year | 
| Pain Scores | Using a uni-dimensional pain score measurement examining the change from baseline. | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, ergonomics, robotics