NCT05116332

Brief Summary

The investigators postulate that there is a difference in the acquisition of Fundamental Laparoscopic Skills (FLS) between general surgical and Obstetrics \& Gynaecology (O\&G) trainees. This discrepancy is also likely to influence the musculoskeletal and cognitive fatigue trainees experience within both specialties. Additionally there is likely to be a discrepancy in the expectations of consultants and trainees on skills perceived to be important at the completion of training (CCT). This study aims to compare and evaluate the discrepancy in FLS acquisition amongst O\&G and GS trainees in order to identify areas for improvements in the training pathway, the associated fatigue experience and highlight the expectations perceived to be required at the completion of training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

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

September 11, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

September 26, 2021

Last Update Submit

March 17, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average time to complete Fundamental Laparoscopic surgery (FLS) tasks.

    Mean Time Taken (in minutes: seconds) to perform FLS task

    Over the duration of the 45 minutes when trainees undertake the FLS tasks

Secondary Outcomes (2)

  • EMG measurements of Maximal Voluntary Contraction (MVC)

    Over the duration of the 45 minutes when trainees undertake the FLS tasks

  • EEG measurements of peak alpha power

    Over the duration of the 45 minutes when trainees undertake the FLS tasks

Study Arms (2)

Obstetrics and Gynaecology (O&G)

Trainees from ST3/ST4/ST5 grades (n=11) and ST6/ST7 grades (n=12). As O\&G training covers both Obstetrics \& Gynaecology curriculums, we will recruit trainees in their final two years of training (i.e. ST6 and ST7) with gynaecology special interest; undertaking at least one gynaecology Advanced Training Skills Modules (ATSM). These include advanced laparoscopic training, open and laparoscopic benign abdomen, urogynaecology, gynaecology-oncology and reproductive medicine. To measure musculoskeletal (Electromyography) and cognitive fatigue (Electroencephalography): A total of 10 trainees had these measured; ST3/4/5 (n=5) and ST6/7 (n=5).

General Surgery (GS)

Trainees from ST3/ST4/ST5 (n=11) and senior trainees from ST7/ST8 (n=11). To measure musculoskeletal (Electromyography) and cognitive fatigue (Electroencephalography): A total of 10 trainees had these measured; ST3/4/5 (n=6) and ST7/8 (n=4)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

22 trainees from GS and 23 trainees from O\&G in the northwest deanery. \- Obstetrics and Gynaecology (O\&G): Junior trainees - ST3/ST4/ST5 (n=11) Senior trainees - ST6/ST7 (n=12) \- General Surgery (GS): ST3/ST4/ST5 (n=11) ST7/ST8 (n=11)

You may qualify if:

  • General surgery trainees at ST3/ST4/ST5/ST7/ST8 levels
  • Obstetrics and Gynaecology (O\&G) at ST3/ST4/ST5/ST6/ST7 levels
  • Consultants and trainees in general surgery and O\&G- For surveys on laparoscopic standards.

You may not qualify if:

  • Those trainees who have had substantial pre-training experience in laparoscopic surgery such as those who have completed another surgical specialty training, have worked as clinical fellows or specialty doctors with substantial exposure to laparoscopic work will be excluded.
  • Those trainees who are currently out of program/training and not doing regular clinical work or those trainees outside the North West deanery will also be excluded.
  • For the safety of others, anybody with a positive Covid-19 test, symptoms, or contact with -someone infected with the virus will be excluded.
  • Currently out of training (maternity leave, Higher degrees not involving any clinical work)
  • Those who have completed another surgical specialty training, have worked as clinical fellows or specialty doctor with significant exposure to operative laparoscopic work.
  • Withdrawal of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

Related Publications (2)

  • Khan ZN, Shrestha D, Shugaba A, Lambert JE, Haslett E, Afors K, Bampouras TM, Subar D, Gaffney C, Clark TJ. What laparoscopic skills are necessary for the certificate of completion of training? A prospective nationwide cross-sectional survey of obstetrics and gynaecology and general surgery trainees and consultants in the UK. BMJ Open. 2025 Mar 29;15(3):e095777. doi: 10.1136/bmjopen-2024-095777.

  • Khan ZN, Shrestha D, Shugaba A, Lambert JE, Clark J, Haslett E, Afors K, Bampouras TM, Gaffney CJ, Subar DA. Comparing proficiency of obstetrics and gynaecology trainees with general surgery trainees using simulated laparoscopic tasks in Health Education England, North-West: a prospective observational study. BMJ Open. 2023 Nov 10;13(11):e075113. doi: 10.1136/bmjopen-2023-075113.

MeSH Terms

Conditions

Mental FatigueFatigueHypersensitivitySprains and Strains

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorImmune System DiseasesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

September 26, 2021

First Posted

November 11, 2021

Study Start

September 11, 2021

Primary Completion

April 30, 2022

Study Completion

March 10, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations