Abdominal HerniaVOLARENCT05253586
Versius or Laparoscopic Abdominal Hernia REpair
An observational study of Abdominal Hernia and Abdominal Surgery, run by Joanne Turner.
Trial summary
This trial will compare laparoscopic and robotic-assisted abdominal 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
- Abdominal Hernia, Abdominal Surgery
- What is being tested?
- Laparoscopic and Robotic
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2024to 31 Mar 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: Pateints diagnosed with an abdominal hernia and are deemed suitable for minimally invasive surgery
Who may be able to join
- Age ≥18 years
- Need for abdominal hernia repair surgery
- Incisional
- Congenital
- Deemed suitable for minimally invasive surgery
Who cannot join
- Patients who are unable to consent
- Prisoners
- Patients in need of emergency surgery
- Patients with a hernial defect size of over 7cm
About this study
Official title: A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Abdominal Hernia Surgery
This trial will compare laparoscopic and robotic-assisted abdominal 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 abdominal hernias. The study will randomise 60 patients who require repair of an abdominal 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.
- Conditions
- Abdominal Hernia, Abdominal Surgery
- Being tested
- Laparoscopic, Robotic
- Keywords
- ergonomics, robotics, versius
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: 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 questionnaire post operatively on day 14. Total scores used not sub scales to be reported.
Measured: Assessed on Day 14
Satisfaction with life scale
Quality of life units completion of MFSI-SF questionnaires post operatively on day 14. Total scores used not sub scales to be reported.
Measured: Assessed on Day 14
Length of in-patient stay
Measure of the time in days of each participant's hospital stay as an in-patient.
Measured: Up to 4 weeks
Pain Scores
Using a uni-dimensional pain score measurement examining the change from baseline.
Measured: Days 1, 2, 3, 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start31 Mar 2024 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Why it stopped: PhD studentship research defined area changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanne Turner
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Joanne Turner, Milton Keynes University Hospital NHS Foundation Trust
- Investigators
- Barrie Keeler, Principal investigator, Consultant Colorectal Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253586
- Sponsor's protocol ID
- MKUH-RD-019
- Acronym
- VOLARE
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 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 Abdominal Hernia Surgery
- ClinicalTrials.gov ID
- NCT05253586
- Acronym / sponsor ID
- VOLARE / MKUH-RD-019
- Conditions
- Abdominal Hernia, Abdominal Surgery
- Keywords
- ergonomics, robotics, versius
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PhD studentship research defined area changed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Joanne TurnerOther government
- Study start
- 31 Mar 2024 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 24 Feb 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 abdominal 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 abdominal hernias. The study will randomise 60 patients who require repair of an abdominal 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Arm | – | Procedure: 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
- Pateints diagnosed with an abdominal hernia and are deemed suitable for minimally invasive surgery
Key inclusion criteria (5 listed)
- Age ≥18 years
- Need for abdominal 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 a hernial defect size of over 7cm
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 |
|---|---|---|
| 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 14
Satisfaction with life scale
Time frame: Assessed on Day 14
Length of in-patient stay
Time frame: Up to 4 weeks
Pain Scores
Time frame: Days 1, 2, 3, 14 and 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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
Consultant Colorectal Surgeon
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Hernia and Abdominal Surgery, run by Joanne Turner.
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 5 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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.