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Impact on Diagnostic Accuracy of a Specific Clinical Ultrasound Practical Teaching

NCT04879459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-02-01

No results posted yet for this study

Summary

This research proposal is a pilot double-blind randomized control trial evaluating the impact on diagnostic accuracy of a Clinical UltraSound (CUS) teaching for gallbladder assessment using exclusively healthy volunteers for practical sessions. Classically, a number of 25 to 50 CUS of the gallbladder is reported to achieve competency. Many CUS curricula or guidelines recommend reporting pathological cases, either a certain amount, either generically, in their core-ultrasound competency requirements. Using healthy volunteers is rarely meant to verify the hypothesis that practical sessions based on exclusively normal patterns combined with presentation of pathological ultrasound loops or images during theoretical sessions, could further allow reaching diagnostic accuracy requirements in clinical practice. In the present study, participants will be medical students in their 5th year, naïve to CUS use. Participants will be randomly be distributed between a control group undergoing a standard practical teaching on models presenting uncomplicated gallstones or normal gallbladder (no gallstones), and an intervention group undergoing a practical teaching exclusively on models presenting a normal gallbladder. Participants will be "blinded" to study endpoints as well as to group allocation. After three days of practical teaching on day 0-10-30, students will be evaluated on day 60 by 2 external investigators blinded to students group allocation. Diagnostic accuracy for gallstones will be measured using sensitivity and specificity. Statistical analysis will be performed blinded to students' name using IBM SPSS statistics 26.0 (SPSS Inc., Chicago, IL, USA). As is classical, the statistical tests will be rejected whenever the observed p-value is smaller than 0.05. Corrections for multiple testing will be used. A comparable diagnostic accuracy between groups could further support the use of healthy volunteers during practical teaching and ease clinical ultrasound curricula. Such a finding wouldn't however carry away the need for enhancing competencies during clinical practice or the need for continuing medical education, as for any medical procedure.

Conditions

  • Gallstone

Interventions

OTHER

Practical sessions to learn CUS exclusively on volunteers presenting a healthy gallbladder

The study days are 1 day apart for CG and IG but follow the exact same organization. Studytake place on day 0-10-30 (+/-2days). Practical sessions to learn CUS are organized either on volunteers presenting a healthy gallbladder or a pathological gallbladder (sludge, gallstones) (CG), either exclusively on volunteers presenting a healthy gallbladder (IG).

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Dominique Vanpee, PhD · Institut de recherche santé et société

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2021-12-11
Completion
2021-12-11

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879459 on ClinicalTrials.gov