Clinical trial NCT05262374: Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair
Official title: A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: surgery
ergonomics
robotics
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
timeFrame: Length of the procedure expected to be between 1-4 hours
Secondary outcomes:
measure: Measurement of the rate of participant recruitment
timeFrame: Through study completion, an average of 1 year.
measure: Measurement of drop-out (withdrawal) rate of participants
timeFrame: Assessed from Day 1 (Randomisation) to date of withdrawal
measure: Measurement of the unblinding rate of participants
timeFrame: Through study completion, an average of 1 year.
measure: Mental strain of surgeon
timeFrame: 30 minutes maximum completion time per surgeon
measure: Health Economics
timeFrame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
measure: Communication
timeFrame: 1-4 hours expected for the duration of the procedure
measure: Satisfaction with life scale
timeFrame: Assessed on Day 1 and Day 14
measure: Satisfaction with life
timeFrame: Assessed on Day 1 and Day 14
measure: Length of in-patient stay
timeFrame: Through study completion, an average of 1 year
measure: Pain Scores
timeFrame: Day 14
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Surgical Division
Study officials:
affiliation: Colorectal surgeon
name: Barrie Keeler
role: PRINCIPAL_INVESTIGATOR
References: