VOLTAIRE: Versius Or Laparoscopic TransAbdominal Inguinal Hernia REpair

Sponsor
Joanne Turner (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05262374
Collaborator
(none)
60
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Pain Scores [Day 14]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Joanne Turner

Investigators

  • Principal Investigator: Barrie Keeler, Colorectal surgeon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joanne Turner, Academic Research Coordinator, Milton Keynes University Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05262374
Other Study ID Numbers:
  • MKUH-RD-021
First Posted:
Mar 2, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joanne Turner, Academic Research Coordinator, Milton Keynes University Hospital NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022