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Completed

NCT Number: NCT06622980

The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores (ErgoEd)

This study aims to determine whether education of surgeons can reduce the physical strain of performing surgery. Laparoscopic surgery is known to be beneficial for patients but can cause both short- and long-term musculoskeletal injuries for the surgeons who perform it. The purpose of the study is to investigate whether the physical risks to surgeons can be reduced by educating them on how to best set up the operating theatre and equipment, and how to optimise their posture and position whilst operating.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Milton Keynes University Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

About this study

This study has been designed to assess whether receiving education in ergonomic principles can lower surgeons' ergonomic risk scores when performing laparoscopic surgery. The study will recruit surgeons who regularly perform laparoscopic surgery, with no stipulations on surgeon speciality. All surgeons will be required to have completed at least 20 laparoscopic cases beforehand.

The primary outcome will be assessed intraoperatively, with additional questionnaire data collected immediately postoperatively. Assessment of ergonomics (REBA score) will be done from still photographs that focus on the operating surgeon, although other team members may be visible in the background. Photographs will be analysed postoperatively by the research team and an overall REBA score calculated for each surgeon.

Other secondary outcomes will be assessed via a questionnaire. After each operation surgeons will complete a subjective cognitive and physical strain questionnaire based on the NASA-TLX and SURG-TLX scales, which are both widely used and validated tools. Additional questions have been added in order to provide data for the development of a new subjective physical strain questionnaire based on pooled data from several surgical ergonomics trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Laparoscopic surgeon from any surgical subspecialty
  • Can commit sufficient time to ergonomic training

Exclusion criteria

  • Training grade more junior than a registrar

Treatment and study plan

Education

Other

The educational intervention will take the form of a video explaining both general ergonomic principles and specific advice for laparoscopic surgeons. This video will be shown to surgeons at a time of their convenience and the research team will be available to answer any further questions at this time.

The educational video will cover both ergonomics principles and specific advice for laparoscopic surgeons. The principles will be relevant to any situation, including those outside the medical field. The laparoscopic-specific section will include tips for optimisation of operating theatre set-up and advice on posture and body position. The video content will be reviewed by experts experienced in surgical ergonomics education to ensure it covers all useful information and is in line with best practice.

Primary outcomes

  1. Rapid Entire Body Assessment (REBA) score

    Time frame: (1) operating list before the intervention - no specified time frame, (2) operating list 1 week after the intervention, (3) operating list 4-6 weeks after the intervention.

    To assess whether receiving education on ergonomics can reduce laparoscopic surgeons' ergonomic risk (REBA) scores whilst operating.

    The risk score is calculated post hoc from photographs taken every 1-minute for the duration of operating for each 3 observed operating lists. One operating list may include more than one operation.

Secondary outcomes

  1. Cognitive and physical strain score

    Time frame: Questionnaire taken immediately at the end of each observed operation.

    To compare surgeons' subjective experience of pain and discomfort intraoperatively.

    This is a modified questionnaire including items from Hart and Staveland's NASA Task Load Index (NASA-TLX) and Wilson et al. the surgery task load index (SURG-TLX).

    Higher scores indicate higher cognitive and physical strain.

  2. Feedback questionnaire on educational intervention

    Time frame: Completed once immediately after the final (third) observed operating list (4-6 weeks after the intervention)).

    To gain feedback on the design of the educational intervention.

  3. Ergonomic knowledge questionnaire

    Time frame: Assessed at baseline - immediately after consent - but prior to first observed operating list (no timeframe specified), and again immediately after final (third) observed operating list (4-6 weeks after the intervention).

    To assess whether surgeons' theoretical knowledge of ergonomic principles can be improved

  4. Acceptability of recruitment and study retention

    Time frame: at the end of the trial (last surgeon's third operating list/4-6 weeks after the last recruited surgeon has received the intervention)

    This measurement is part of the feasibility of a future larger-scale study. This is measured through an assessment of how many participants decline to participate or withdraw from the study.

Sponsors and collaborators

Lead sponsor

Milton Keynes University Hospital NHS Foundation Trust

Other Gov

Registry information

Official study title

The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores

Acronym: ErgoEd

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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