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Clinical Trials/NCT05253586
NCT05253586WithdrawnNot Applicable

A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Abdominal Hernia Surgery

Joanne Turner0 sites60 target enrollmentStarted: March 31, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
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

Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Joanne Turner

Academic Research Coordinator

Milton Keynes University Hospital NHS Foundation Trust

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