Inguinal HerniaVOLTAIRENCT05262374
Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair
An observational study of Inguinal Hernia, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Procedure/Surgery: Laparoscopic and Robotic
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2023to 5 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age ≥18 years
- Need for inguinal hernia repair surgery
- Deemed suitable for minimally invasive surgery
Who cannot join
- Patients who are unable to consent
- Prisoners
- Patients in need of emergency surgery
- Patients with inguinoscrotal or recurrent inguinal hernias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Procedure/Surgery: Laparoscopic, Robotic
- Keywords
- surgery, ergonomics, robotics
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: LaparoscopicProcedure or surgery
Surgeon
RoboticProcedure or surgery
Versius system.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Arm | This cohort of participants will have their procedure completed by a human surgeon Receives: Procedure: Procedure/Surgery: Laparoscopic | |
| Robotic Arm | This cohort of participants will have their procedure completed by the Versius Surgical Robotic System. Receives: Procedure: Robotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Length of the procedure expected to be between 1-4 hours
Secondary outcomes (10)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Pain Scores
Using a uni-dimensional pain score measurement examining the change from baseline.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 Feb 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Barrie Keeler, Principal investigator, Colorectal surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262374
- Sponsor's protocol ID
- MKUH-RD-021
- Acronym
- VOLTAIRE
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery
- ClinicalTrials.gov ID
- NCT05262374
- Acronym / sponsor ID
- VOLTAIRE / MKUH-RD-021
- Conditions
- Inguinal Hernia
- Keywords
- surgery, ergonomics, robotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation TrustOther government
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Arm | – | Procedure: Procedure/Surgery: LaparoscopicThis cohort of participants will have their procedure completed by a human surgeon |
| Robotic Arm | – | Procedure: RoboticThis cohort of participants will have their procedure completed by the Versius Surgical Robotic System. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Age ≥18 years
- Need for inguinal hernia repair surgery
- Deemed suitable for minimally invasive surgery
Key exclusion criteria (4 listed)
- Patients who are unable to consent
- Prisoners
- Patients in need of emergency surgery
- Patients with inguinoscrotal or recurrent inguinal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure/Surgery: LaparoscopicSurgeon | Procedure or surgery | Laparoscopic Arm |
| RoboticVersius system. | Procedure or surgery | Robotic Arm |
Primary outcome
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
10 secondary outcomes
Measurement of the rate of participant recruitment
Time frame: Through study completion, an average of 1 year.
Measurement of drop-out (withdrawal) rate of participants
Time frame: Assessed from Day 1 (Randomisation) to date of withdrawal
Measurement of the unblinding rate of participants
Time frame: Through study completion, an average of 1 year.
Mental strain of surgeon
Time frame: 30 minutes maximum completion time per surgeon
Health Economics
Time frame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
Communication
Time frame: 1-4 hours expected for the duration of the procedure
Satisfaction with life scale
Time frame: Assessed on Day 1 and Day 14
Satisfaction with life
Time frame: Assessed on Day 1 and Day 14
Length of in-patient stay
Time frame: Through study completion, an average of 1 year
Pain Scores
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrie Keeler principal investigator
Colorectal surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.