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Completed

NCT Number: NCT05262374

Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair

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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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Division

Milton Keynes, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedure/Surgery: Laparoscopic

Procedure

Surgeon

Robotic

Procedure

Versius system.

Primary outcomes

  1. To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery

    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

Secondary outcomes

  1. Measurement of the rate of participant recruitment

    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

  2. Measurement of drop-out (withdrawal) rate of participants

    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.

  3. Measurement of the unblinding rate of participants

    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.

  4. Mental strain of surgeon

    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.

  5. Health Economics

    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.

  6. Communication

    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.

  7. Satisfaction with life scale

    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.

  8. Satisfaction with life

    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.

  9. Length of in-patient stay

    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.

  10. Pain Scores

    Time frame: Day 14

    Using a uni-dimensional pain score measurement examining the change from baseline.

Sponsors and collaborators

Lead sponsor

Milton Keynes University Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: VOLTAIRE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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