Surgery, LaparoscopicErgoEdNCT06622980
The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores (ErgoEd)
A study testing Education in people with Surgery, Laparoscopic, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery, Laparoscopic
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Feb 2024to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laparoscopic surgeon from any surgical subspecialty
- Can commit sufficient time to ergonomic training
Who cannot join
- Training grade more junior than a registrar
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Milton Keynes University Hospital
Milton Keynes, Buckinghamshire, MK6 5LD
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery, Laparoscopic
- Being tested
- Education
- Keywords
- laparoscopic surgery, ergonomics, ergonomic education, Ergonomic Risk Score, REBA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgeons | Experimental | Laparoscopic surgeons from any surgical subspecialty Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (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
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: at the end of the trial (last surgeon's third operating list/4-6 weeks after the last recruited surgeon has received the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start21 Feb 2024
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pre-post study with the educational intervention taking place outside of the clinical setting.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Barrie Keeler, Principal investigator, Milton Keynes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622980
- Sponsor's protocol ID
- MKUH-RD-027
- Other IDs
- 332452
- Acronym
- ErgoEd
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: R\&D will evaluate requests on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Ergonomic Educational Intervention on Laparoscopic Surgeons' Ergonomic Risk Scores
- ClinicalTrials.gov ID
- NCT06622980
- Acronym / sponsor ID
- ErgoEd / MKUH-RD-027
- Conditions
- Surgery, Laparoscopic
- Keywords
- laparoscopic surgery, ergonomics, ergonomic education, Ergonomic Risk Score, REBA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Milton Keynes University Hospital NHS Foundation TrustOther government
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pre-post study with the educational intervention taking place outside of the clinical setting.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgeons | Experimental | Other: EducationLaparoscopic surgeons from any surgical subspecialty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Laparoscopic surgeon from any surgical subspecialty
- Can commit sufficient time to ergonomic training
Key exclusion criteria (1 listed)
- Training grade more junior than a registrar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThe 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. | Other | Laparoscopic surgeons |
Primary outcome
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.
4 secondary outcomes
Cognitive and physical strain score
Time frame: Questionnaire taken immediately at the end of each observed operation.
Feedback questionnaire on educational intervention
Time frame: Completed once immediately after the final (third) observed operating list (4-6 weeks after the intervention)).
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Undecided. R\&D will evaluate requests on a case-by-case basis.
Related trials for Surgery, Laparoscopic
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrie Keeler principal investigator
Milton Keynes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Surgery, Laparoscopic, run by Milton Keynes University Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.