Clinical trial NCT06622980: The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores (ErgoEd)
Official title: The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery, Laparoscopic
Keywords: laparoscopic surgery
ergonomics
ergonomic education
Ergonomic Risk Score
REBA
Lead sponsor: Milton Keynes University Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2024-10-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pre-post study with the educational intervention taking place outside of the clinical setting.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• Training grade more junior than a registrar

Primary outcomes:
measure: Rapid Entire Body Assessment (REBA) score
timeFrame: (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 outcomes:
measure: Cognitive and physical strain score
timeFrame: Questionnaire taken immediately at the end of each observed operation.
measure: Feedback questionnaire on educational intervention
timeFrame: Completed once immediately after the final (third) observed operating list (4-6 weeks after the intervention)).
measure: Ergonomic knowledge questionnaire
timeFrame: 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).
measure: Acceptability of recruitment and study retention
timeFrame: at the end of the trial (last surgeon&#39;s third operating list/4-6 weeks after the last recruited surgeon has received the intervention)
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes University Hospital
state: Buckinghamshire
Study officials:
affiliation: Milton Keynes University Hospital
name: Barrie Keeler
role: PRINCIPAL_INVESTIGATOR
References: