NCT06622980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 24, 2024

Last Update Submit

September 30, 2024

Conditions

Keywords

laparoscopic surgeryergonomicsergonomic educationErgonomic Risk ScoreREBA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cognitive and physical strain score

    Questionnaire taken immediately at the end of each observed operation.

  • Feedback questionnaire on educational intervention

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

  • 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)

Study Arms (1)

Laparoscopic surgeons

EXPERIMENTAL

Laparoscopic surgeons from any surgical subspecialty

Other: Education

Interventions

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.

Laparoscopic surgeons

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Training grade more junior than a registrar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton Keynes University Hospital

Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Barrie Keeler

    Milton Keynes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single arm pre-post study with the educational intervention taking place outside of the clinical setting.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 2, 2024

Study Start

February 21, 2024

Primary Completion

September 12, 2024

Study Completion

September 12, 2024

Last Updated

October 2, 2024

Record last verified: 2024-09

Locations