Clinical trial NCT05253586: Versius or Laparoscopic Abdominal Hernia REpair
Official title: A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Abdominal Hernia Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Abdominal Hernia
Abdominal Surgery
Keywords: ergonomics
robotics
versius
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-02-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pateints diagnosed with an abdominal hernia and are deemed suitable for minimally invasive surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery
timeFrame: Length of the procedure expected to be between 1-4 hours
Secondary outcomes:
measure: Measurement of the rate of participant recruitment
timeFrame: Through study completion, an average of 1 year.
measure: Measurement of drop-out (withdrawal) rate of participants
timeFrame: Assessed from Day 1 (Randomisation) to date of withdrawal
measure: Measurement of the unblinding rate of participants
timeFrame: Through study completion, an average of 1 year.
measure: Mental strain of surgeon
timeFrame: 30 minutes maximum completion time per surgeon
measure: Health Economics
timeFrame: Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
measure: Communication
timeFrame: 1-4 hours expected for the duration of the procedure
measure: Satisfaction with life scale
timeFrame: Assessed on Day 14
measure: Satisfaction with life scale
timeFrame: Assessed on Day 14
measure: Length of in-patient stay
timeFrame: Up to 4 weeks
measure: Pain Scores
timeFrame: Days 1, 2, 3, 14 and 28
Other outcomes:
Locations:
Study officials:
affiliation: Consultant Colorectal Surgeon
name: Barrie Keeler
role: PRINCIPAL_INVESTIGATOR
References: