Web-based Learning Module to Increase the Accuracy of Optical Diagnosis for Detecting the Invasive Pattern of Colorectal Polyps (LODIP Study). Randomised Controlled Trial

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

International guidelines recommend deciding the treatment of colorectal lesions based on the estimated histology by endoscopic optical diagnosis. However, the theoretical and practical knowledge on optical diagnosis is not widely expanded The mail goal of this randomised controlled trial is to compare the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies of gastroenterologists attending a e-learning module (intervention group) vs gastroenterologists who do not (control group) The main questions the study aims to answer are: * Is the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? * Is the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps ≥ 20 mm assessed in routine colonoscopies increased in those gastroenterologists participating in the e-learning module? * In lesions with submucosal invasion, is the en bloc and complete resection rate (R0) increased in those gastroenterologists participating in the e-learning module? * In lesions referred to surgery, is the pooled benign polyps rate decreased in those gastroenterologists participating in the e-learning module? * In lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection), is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in those gastroenterologists participating in the e-learning module? * In lesions treated with piecemeal endoscopic resection, is the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in those gastroenterologists participating in the e-learning module? * Is the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures increased after participating in the e-learning module? The participants (or subjects of study) are gastroenterologists. They will be randomised to do the e-learning course (intervention group) or not (control group). Researchers will compare clinical outcomes of gastroenterologists participating in the e-learning module vs gastroenterologists not participating in the e-learning module to see if: * the pooled sensitivity of optical diagnosis for predicting deep submucosal invasion in large non-pedunculated polyps \> 20 mm assessed in routine colonoscopies is increased. * the pooled diagnostic accuracy of optical diagnosis for predicting deep sm invasion in large non-pedunculated polyps \> 20 mm is increased. * the en bloc and complete resection rate (R0) is increased in lesions with submucosal invasion. * the pooled benign polyps rate decreased in lesions referred to surgery. * the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion increased in lesions treated with advanced en bloc procedures (ESD, TAMIS, fullthickness resection). * the pooled rate of histology with high-grade dysplasia, intramucosal cancer or submucosal invasion decreased in lesions treated with piecemeal endoscopic resection. * the diagnostic accuracy for predicting deep submucosal invasion in a test with pictures after participating is increased.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 28
Healthy Volunteers: t
View:

• Gastroenterologists who have performed \> 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
ACTIVE_NOT_RECRUITING
Chapel Hill
Other Locations
Japan
National Cancer Center
ACTIVE_NOT_RECRUITING
Chūō
Spain
Hospital Comarcal de Alcañiz
ACTIVE_NOT_RECRUITING
Alcañiz
Hospital Germans Trias i Pujol
ACTIVE_NOT_RECRUITING
Badalona
Hospital Clínic i Provincial de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Clínico Universitario Virgen de la Arrixaca
ACTIVE_NOT_RECRUITING
El Palmar
Hospital Universitario 12 de Octubre
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
ACTIVE_NOT_RECRUITING
Madrid
Althaia Xarxa Assistencial Universitària de Manresa
RECRUITING
Manresa
Consorci Sanitari de Terrassa
ACTIVE_NOT_RECRUITING
Terrassa
Hospital Universitari i Politècnic La Fe
ACTIVE_NOT_RECRUITING
Valencia
United Kingdom
Nottingham University Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Nottingham
Contact Information
Primary
Anna Arnau, PhD
aarnau@althaia.cat
+34938759300
Backup
Anna Cano, BAJ
goesresearchgroup@althaia.cat
+34938759300
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2024-03-31
Participants
Target number of participants: 166
Treatments
Experimental: E-learning module gastroenterologists
Gastroenterologists participating in the e-learning module
No_intervention: Control group
Gastroenterologists not participating in the e-learning module
Sponsors
Collaborators: Asociación Española de Gastroenterología, Spanish Society of Digestive Endoscopy, Fundació La Marató de TV3
Leads: Althaia Xarxa Assistencial Universitària de Manresa

This content was sourced from clinicaltrials.gov