Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair (VOLTAIRE)

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

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Procedure/Surgery: Laparoscopic; Procedure: Robotic

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United Kingdom
  • Milton Keynes, United Kingdom
    • Surgical Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic Arm; This cohort of participants will have their procedure completed by a human surgeon	Procedure: Procedure/Surgery: Laparoscopic; Surgeon
Robotic Arm; This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.	Procedure: Robotic; Versius system.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton Keynes University Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Barrie Keeler, Colorectal surgeon

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: surgery; robotics; ergonomics
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: MKUH-RD-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No