- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05253586
Versius Or Laparoscopic Abdominal Hernia REpair (VOLARE)
March 13, 2024 updated by: Joanne Turner
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joanne Turner
- Phone Number: +441908995136
- Email: joanne.turner@mkuh.nhs.uk
Study Contact Backup
- Name: Antoanela Colda
- Phone Number: +441908995119
- Email: antoanela.colda@mkuh.nhs.uk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Pateints diagnosed with an abdominal hernia and are deemed suitable for minimally invasive surgery
Description
Inclusion Criteria:
- Age ≥18 years
Need for abdominal hernia repair surgery
- Incisional
- Congenital
- Deemed suitable for minimally invasive surgery
Exclusion Criteria:
- Patients who are unable to consent
- Prisoners
- Patients in need of emergency surgery
- Patients with a hernial defect size of over 7cm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Robotic Arm
This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.
|
Versius system
|
Laparoscopic Arm
This cohort of participants will have their procedure completed by a human surgeon.
|
Surgeon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Length of the procedure expected to be between 1-4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of drop-out (withdrawal) rate of participants
Time Frame: 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.
|
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.
|
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.
|
Through study completion, an average of 1 year.
|
Mental strain of surgeon
Time Frame: 30 minutes maximum completion time per surgeon
|
To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score.
|
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.
|
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.
|
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
|
To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.
|
1-4 hours expected for the duration of the procedure
|
Measurement of the rate of participant recruitment
Time Frame: 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.
|
Through study completion, an average of 1 year.
|
Satisfaction with life scale
Time Frame: Assessed on Day 14
|
Quality of life units completion of EQ-5D-5L questionnaire post operatively on day 14.
Total scores used not sub scales to be reported.
|
Assessed on Day 14
|
Satisfaction with life scale
Time Frame: Assessed on Day 14
|
Quality of life units completion of MFSI-SF questionnaires post operatively on day 14.
Total scores used not sub scales to be reported.
|
Assessed on Day 14
|
Length of in-patient stay
Time Frame: Up to 4 weeks
|
Measure of the time in days of each participant's hospital stay as an in-patient.
|
Up to 4 weeks
|
Pain Scores
Time Frame: Days 1, 2, 3, 14 and 28
|
Using a uni-dimensional pain score measurement examining the change from baseline.
|
Days 1, 2, 3, 14 and 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barrie Keeler, Consultant Colorectal Surgeon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 31, 2024
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
January 4, 2022
First Submitted That Met QC Criteria
February 21, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MKUH-RD-019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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