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

Not Applicable

Completed

• Conditions: Surgery, Laparoscopic
• Interventions: Other: Education

• Registration Number: NCT06622980
• Lead Sponsor: Milton Keynes University Hospital NHS Foundation Trust

Brief Summary

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.

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 Timeline

• Study Start: 2024-02-21
• Status Verified: 2024-09
• Primary Completion: 2024-09-12
• Study Completion: 2024-09-12
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic surgeons	Education	Laparoscopic surgeons from any surgical subspecialty

Primary Outcome Measures

Name	Time	Method
Rapid Entire Body Assessment (REBA) score	(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 Outcome Measures

Name	Time	Method
Cognitive and physical strain score	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.
Feedback questionnaire on educational intervention	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.
Ergonomic knowledge questionnaire	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
Acceptability of recruitment and study retention	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.

Trial Locations

Locations (1)

Milton Keynes University Hospital; 🇬🇧 Milton Keynes, Buckinghamshire, United Kingdom