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Impact of minimally invasive surgery on surgeon health

Impact of minimally invasive surgery on surgeon health: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11807724
Enrollment
165
Registered
2022-03-04
Start date
2022-01-10
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgeons performing live surgical procedures (open/laparoscopic/robotic). Surgery

Interventions

This study aims to develop and validate a 5-point assessment tool to objectively measure both the physical and psychological impact of complex surgical cases on a surgeon, in order to give a single ca
continuous movement sensor monitoring
State Trait Anxiety Inventory questionnaire
and musculoskeletal symptoms questionnaire. Patients will be consented for their surgeon to undergo monitoring during their surgical procedure.

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Surgeons: 1. Consultant Surgeons and Gynaecologists 2. Able to consent 3. Patient consents to their surgeon participating in the study Patients: 1. All patients 2. Able to consent 3. Undergoing intra-abdominal surgery with a procedure expected to last less than 2 hours in duration 4. Aged >18 years

Exclusion criteria

Exclusion criteria: Patients who do not consent for their surgeon to participate

Design outcomes

Primary

MeasureTime frame
The proportion of surgical procedures where all five variables of the assessment tool are captured (continuous heart rate [HR] monitoring; salivary cortisol (taken pre-, intra- and post-operatively); continuous movement sensor monitoring; State-Trait Anxiety Inventory (STAI) questionnaire and modified Nordic work-related musculoskeletal symptoms (WMS) questionnaire), taken pre- and post-operatively

Secondary

MeasureTime frame
1. A single value of ‘impact’ (high/intermediate/low) per procedure calculated by combining the five recorded variables will be calculated on completion of participant recruitment to the feasibility cohort 2. Validation of the calculated ‘impact’ values by comparison of surgeon’s subjective assessment of case complexity with objective measures will be calculated on completion of participant recruitment to the validation cohort 3. Analysis of the impact on surgeons of supervising surgical trainees measured using heart rate monitoring and salivary cortisol levels intraoperatively 4. Willingness of recruitment of patients and surgeons and sample size calculations for a future multi-centre study comparing the impact of the route of surgery on the surgeon, measured using recruitment and retention rates on completion of participant recruitment to the feasibility cohort 5. Primary/secondary outcomes for a future definitive multi-centre study comparing the impact of the route of surgery on the surgeon, identified using qualitative interview data on completion of participant recruitment to the feasibility cohort 6. Optimisation and validation of patient data recording measures to capture anaesthetic/operative/clinical events and outcomes using analysis of collected quantitative data on completion of participant recruitment to the feasibility cohort 7. Safety of measurement tools and recording devices in the theatre environment assessed using a Medical Physics assessment before commencing participant/surgeon recruitment 8. Optimisation of surgeon continuous heart rate monitoring during the procedure, quality and completeness of data collection and analysis, assessed using interview and quantitative data on completion of participant recruitment to the feasibility cohort 9. Optimisation of positioning and recording of muscle movement/activity sensors and streamlining of data-analysis using interview and quantitative data at on completion of participant recruitment to the feasib

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026