NCT05887570

Brief Summary

Funding for resident training is continually decreasing. The investigators hope to look at innovative ways to improve resident education. The project will investigate whether skills acquired in a surgical lab result in improved operating room (OR) surgical skills. This will be a randomized controlled trial that will split residents up into an intervention group and a control group. The intervention group will be required to pass training modules for six essential surgeries before operating in the OR. In the OR, both groups will be graded by the supervising doctor and be asked to rate themselves using validated questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 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

June 13, 2011

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

13.1 years

First QC Date

May 4, 2023

Last Update Submit

October 16, 2024

Conditions

Keywords

education

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome - investigation of whether procedure-specific skills acquired in surgical lab

    To investigate whether procedure-specific skills acquired in a surgical lab result in improved OR surgical skills as tested via a global rating scale on each of several index procedures.

    through study completion, on average 1 year

Secondary Outcomes (5)

  • Secondary Outcome 1 - Improved Knowledge

    through study completion, on average 1 year

  • Secondary Outcome 2 - Less OR Time

    through study completion, on average 1 year

  • Secondary Outcome 3 - Implemention of modular training

    through study completion, on average 1 year

  • Seconday Outcome 4 - remedial training

    through study completion, on average 1 year

  • Secondary Outcome 6 - Resident satisfaction and self confidence

    through study completion, on average 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Specific intervention: Modules for each of the above comprising: 1. didactic lecture on indications and contraindications of procedure, surgical anatomy, patient positioning in the OR, anesthesia type, suture materials and suturing techniques; 2. practical component with hands-on surgical skill training in basic and advanced techniques relevant to each procedure 3. immediate feedback from dedicated educator on technical aspects 4. post-test

Behavioral: Educational intervention

Control -

PLACEBO COMPARATOR

This group receives regular instruction.

Other: Control - Regular Instruction

Interventions

intervention through extra education, modules, instruction on models

Intervention

participants receive usual training

Control -

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An Obstetrics and Gynaecology residents/medical students/ fellow/junior staff in the UBC program General surgery residents Willing to participate Previous performance of less than 5 of each of the index procedures independently in the OR

You may not qualify if:

  • Previous performance of 5 or more of each of the index procedures independently in the OR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (1)

  • Geoffrion R, Koenig NA, Cundiff GW, Flood C, Hyakutake MT, Schulz J, Brennand EA, Lee T, Singer J, Todd NJ. Procedure-specific simulation for vaginal surgery training: A randomized controlled trial. Acta Obstet Gynecol Scand. 2024 Jun;103(6):1165-1174. doi: 10.1111/aogs.14810. Epub 2024 Feb 21.

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes Assessor is blinded.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Educational Intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2023

First Posted

June 2, 2023

Study Start

June 13, 2011

Primary Completion

July 2, 2024

Study Completion

July 2, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations