Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Robotic

• Registration Number: NCT05262374
• Lead Sponsor: Milton Keynes University Hospital NHS Foundation Trust

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2023-02-09
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Robotic Arm	Robotic	This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.

Primary Outcome Measures

Name	Time	Method
To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery	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 Outcome Measures

Name	Time	Method
Health Economics	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.
Communication	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.
Length of in-patient stay	Through study completion, an average of 1 year	Measure of the time in days of each participant's hospital stay as an in-patient.
Pain Scores	Day 14	Using a uni-dimensional pain score measurement examining the change from baseline.
Mental strain of surgeon	30 minutes maximum completion time per surgeon	To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score.
Satisfaction with life scale	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.
Measurement of the rate of participant recruitment	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
Measurement of drop-out (withdrawal) rate of participants	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.
Measurement of the unblinding rate of participants	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.
Satisfaction with life	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.

Trial Locations

Locations (1)

Surgical Division; 🇬🇧 Milton Keynes, United Kingdom