VOLTAIRE, v1
Research type
Research Study
Full title
VOLTAIRE - Versius Or Laparoscopic TransAbdominal Inguinal hernia REpair. A single blinded randomised controlled trial comparing the ergonomics of laparoscopic and Versius robotic assisted inguinal hernia surgery
IRAS ID
311108
Contact name
Frances Dixon
Contact email
Sponsor organisation
Milton Keynes University Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
This is a study comparing inguinal hernia surgery done via conventional keyhole (laparoscopic) surgery with robotic-assisted keyhole surgery, using the Versius robotic system. Our main objective is to assess the physical strain of both types of surgery on the operating surgeon, but we will also collect data on the patient outcomes and teamwork. This will be used to guide the design of a larger scale trial in future.
Robotic-assisted surgery is increasing in its use in general surgery, as it is thought that the instruments give more precision and stability for complex operations. There is no automation and the robot is under the surgeon's control at all times. Because the surgeon sits at a control console instead of standing by the bedside, robotic-assisted surgery may be better for the surgeon in terms of physical strain. Chronic pain and long-term injuries are common amongst surgeons and so this is an important area of investigation.
To assess physical strain we will use photographs of the operating surgeon and will measure joint position using a scale called Rapid Entire Body Assessment. We will assess mental strain using a questionnaire, and will record video of the surgical team to look at overall team functioning during the operation.
Any patients who are having inguinal hernia repair surgery (and who are suitable for keyhole surgery) may potentially be suitable to take part in this trial. The participant will not know whether they have had robotic or normal keyhole surgery. There will be no additional hospital visits or invasive tests associated with being in this study, but participants will need to complete 2 questionnaires twice. Robotic-assisted surgery is currently used within the NHS and it is known to be a safe treatment option.
Summary of Results
Keyhole surgery is beneficial to patients (in comparison to traditional open surgery with larger cuts) but it has been shown to be physically stressful to perform, and can lead to pain and injury in surgeons. The VOLTAIRE trial aimed to determine whether using a robot could reduce the physical strain on surgeons when performing groin (inguinal) hernia repair surgery, and compared standard keyhole to robotic-assisted surgery. The trial involved 59 patients. We found that using the robot led to significantly less physical strain, but did not have any effect on patients or on team communication or mental strain. The robotic operations took longer. Robotic surgery is already being used more widely within the NHS, and VOLTAIRE shows that there may be additional benefits that have not been fully explored, but this must be balanced with the longer operating times.
Many thanks to all of our trial participants.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0091
Date of REC Opinion
7 Jun 2022
REC opinion
Further Information Favourable Opinion