Surgical Division
Milton Keynes, United Kingdom
NCT Number: NCT05262374
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.
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Notify Me18 year–100 year
All sexes
Observational
Milton Keynes, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgeon
Versius system.
Time frame: Length of the procedure expected to be between 1-4 hours
body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score
Time frame: Through study completion, an average of 1 year.
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: Assessed from Day 1 (Randomisation) to date of withdrawal
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: Through study completion, an average of 1 year.
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: 30 minutes maximum completion time per surgeon
To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score.
Time frame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
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: 1-4 hours expected for the duration of the procedure
To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.
Time frame: Assessed on Day 1 and Day 14
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
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: Through study completion, an average of 1 year
Measure of the time in days of each participant's hospital stay as an in-patient.
Time frame: Day 14
Using a uni-dimensional pain score measurement examining the change from baseline.
Milton Keynes University Hospital NHS Foundation Trust
Other Gov
A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery
Acronym: VOLTAIRE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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