RECRUITING

Web-based Learning Module on Optical Diagnosis of Early Colorectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-01
Study Completion:2024-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05663788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:28 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Gastroenterologists who have performed \> 300 colonoscopies without supervision and are in the last training year or had finished the Gastroenterology residency after 2014.
  1. * Endoscopists who have learned the invasive pattern in a centre where endoscopists have published a high diagnostic accuracy for predicting deep submucosal invasion (Japanese centres).

Contacts and Locations

Study Contact

Anna Arnau, PhD
CONTACT
+34938759300
aarnau@althaia.cat
Anna Cano, BAJ
CONTACT
+34938759300
goesresearchgroup@althaia.cat

Principal Investigator

Ignasi Puig, PhD
PRINCIPAL_INVESTIGATOR
Althaia Xarxa Assistencial Universitària de Manresa

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

  • Ignasi Puig, PhD, PRINCIPAL_INVESTIGATOR, Althaia Xarxa Assistencial Universitària de Manresa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01
Study Completion Date2024-03-31

Study Record Updates

Study Start Date2022-07-01
Study Completion Date2024-03-31

Terms related to this study

Keywords Provided by Researchers

  • advance endoscopy
  • collaborative research
  • colonoscopy
  • early colorectal cancer
  • colorectal polyps
  • optical diagnosis
  • training
  • invasive pattern
  • magnifying endoscopy
  • chromoendoscopy
  • deep submucosal invasion

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Colorectal Cancer Stage I