A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Abdominal Hernia Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Joanne Turner
- Enrollment
- 60
- Primary Endpoint
- To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Mental strain of surgeon(30 minutes maximum completion time per surgeon)
- Measurement of the rate of participant recruitment(Through study completion, an average of 1 year.)
- Measurement of the unblinding rate of participants(Through study completion, an average of 1 year.)
- Satisfaction with life scale(Assessed on Day 14)
- Measurement of drop-out (withdrawal) rate of participants(Assessed from Day 1 (Randomisation) to date of withdrawal)
- Communication(1-4 hours expected for the duration of the procedure)
- Health Economics(Procedure and recovery inpatient stay per participant expected to be between 1-3 days.)
- Length of in-patient stay(Up to 4 weeks)
- Pain Scores(Days 1, 2, 3, 14 and 28)
Investigators
Joanne Turner
Academic Research Coordinator
Milton Keynes University Hospital NHS Foundation Trust