- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02425657
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments
Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.
The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.
The training program for junior doctors consist of the following:
- Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
- 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
- MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
- Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
-
Aalborg, Danemark, 9000
- Recrutement
- NordSim, Aalborg University Hospital
-
Contact:
- Lasse L Pedersen, m.d.
- Numéro de téléphone: +4597661212
- E-mail: lasse.pedersen@rn.dk
-
Chercheur principal:
- Inge Bernstein, PhD, MHM
-
Hjörring, Danemark, 9800
- Recrutement
- Hjörring Hospial
-
Contact:
- Lasse Pedersen, m.d.
- Numéro de téléphone: +45 97661212
- E-mail: lasse.pedersen@rn.dk
-
-
Jutland
-
Hobro, Jutland, Danemark, 9500
- Recrutement
- Aalborg University Hospital:Hobro
-
Contact:
- Lasse Pedersen, m.d.
- Numéro de téléphone: +45 97661212
- E-mail: lasse.pedersen@rn.dk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Doctors currently enrolled in PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
- Able to arrange colonoscopy training in such a way that the total program can be completed in 12 weeks.
- Able to perform supervised upper endoscopy.
Exclusion Criteria:
- Less than 4 months left at current job position.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Junior Doctors
Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).
|
Training program
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
MCSAT (Mayo Clinical Skills Assessment Tool)
Délai: 12 weeks
|
Measured at day 0,5,10,15 and 20.
|
12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Endoscopy training computer generated data - Percentage of colon visualized
Délai: 12 weeks
|
Computer generated score (Simulator test performed at day 0, 10 and 20)
|
12 weeks
|
|
Endoscopy training computer generated data - Time to cecum
Délai: 12 weeks
|
Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)
|
12 weeks
|
|
Endoscopy training computer generated data - Estimated patient pain
Délai: 12 weeks
|
Computer generated score (Simulator test performed at day 0, 10 and 20)
|
12 weeks
|
|
Endoscopy training computer generated data: Percentage spent with clear view
Délai: 12 weeks
|
Computer generated score (Simulator test performed at day 0, 10 and 20)
|
12 weeks
|
|
Endoscopy training computer generated data - Total score
Délai: 12 weeks
|
Computer generated score (Simulator test performed at day 0, 10 and 20)
|
12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Lasse Pedersen, m.d., Aaborg University Surgical Department
Publications et liens utiles
Publications générales
- Sedlack RE. Training to competency in colonoscopy: assessing and defining competency standards. Gastrointest Endosc. 2011 Aug;74(2):355-366.e1-2. doi: 10.1016/j.gie.2011.02.019. Epub 2011 Apr 23. Erratum In: Gastrointest Endosc. 2011 Sep;74(3):729.
- Fried GM, Marks JM, Mellinger JD, Trus TL, Vassiliou MC, Dunkin BJ. ASGE's assessment of competency in endoscopy evaluation tools for colonoscopy and EGD. Gastrointest Endosc. 2014 Aug;80(2):366-7. doi: 10.1016/j.gie.2014.03.019. No abstract available.
- Preisler L, Svendsen MBS, Nerup N, Svendsen LB, Konge L. Simulation-based training for colonoscopy: establishing criteria for competency. Medicine (Baltimore). 2015 Jan;94(4):e440. doi: 10.1097/MD.0000000000000440.
- Kaminski MF, Anderson J, Valori R, Kraszewska E, Rupinski M, Pachlewski J, Wronska E, Bretthauer M, Thomas-Gibson S, Kuipers EJ, Regula J. Leadership training to improve adenoma detection rate in screening colonoscopy: a randomised trial. Gut. 2016 Apr;65(4):616-24. doi: 10.1136/gutjnl-2014-307503. Epub 2015 Feb 10.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AalborgH1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .