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

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery, Laparoscopic
• Intervention / Treatment: Other: Education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Buckinghamshire
    • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
      • Milton Keynes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Training grade more junior than a registrar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Laparoscopic surgeons; Laparoscopic surgeons from any surgical subspecialty

Other: Education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rapid Entire Body Assessment (REBA) score	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.	(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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive and physical strain score	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.	Questionnaire taken immediately at the end of each observed operation.
Feedback questionnaire on educational intervention	To gain feedback on the design of the educational intervention.	Completed once immediately after the final (third) observed operating list (4-6 weeks after the intervention)).
Ergonomic knowledge questionnaire	To assess whether surgeons' theoretical knowledge of ergonomic principles can be improved	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).
Acceptability of recruitment and study retention	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.	at the end of the trial (last surgeon's third operating list/4-6 weeks after the last recruited surgeon has received the intervention)

Collaborators and Investigators

• Sponsor: Milton Keynes University Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Barrie Keeler, Milton Keynes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Actual): September 12, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: September 24, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic surgery; ergonomics; ergonomic education; Ergonomic Risk Score; REBA
• Other Study ID Numbers: MKUH-RD-027; 332452 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: R&D will evaluate requests on a case-by-case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No