Study of Photographs of Interest in Training to Obtain Good Reproducibility of the Diagnosis of Perianal Lesions of Crohn's Disease Inspection in Internal Gastroenterology

Crohn Clinical Trial

— PhotoCrohn  

Official title:

Study of Photographs of Interest in Training to Obtain Good Reproducibility of the Diagnosis of Perianal Lesions of Crohn's Disease Inspection in Internal Gastroenterology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842450
• Other study ID #: PhotoCrohn
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: September 7, 2017
• Start date: June 30, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2017
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and possibly additional examinations including endoscopy and imaging; any of these steps of the diagnosis can only be replaced by another.

In the absence of data in the literature on the evaluation of specific LAP Crohn inspection, Clemence Horaist et al established definitions of these lesions inspection with the help of an expert group, then evaluated the diagnostic agreement LAP these definitions in the same group from a selection of photographs. Definitions ulceration, fistula, inflammatory external os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)

The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014. The interns Hepato gastroenterology must learn during their training to know the terminology of LAP Crohn inspection and to recognize so considered acceptable by experts.

Description:

Study Objectives:

In this context, the investigators work is to show that training giving the consensus definitions of Crohn's lesions on inspection and typical images of these lesions is effective to enable students to achieve a level of diagnosis of these lesions acceptable to experts (ideally not significantly different from that of the experts). Assuming alternates, we will identify difficult diagnosis of lesions for students to find the most appropriate teaching method

Inclusion criteria: all Gastroenterology Hepato-house of France (including overseas territories)

Methodology:

non-interventional multicentre prospective study

February 2015 to July 2015

Statistical analysis: Clinical Research Centre of the coordinating center. Quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages.

Development of the study:

• A broad group of experts (19 proctology and a dermatologist) will be contacted to choose two typical images of LAP (superficial ulceration, deep ulceration ...) from a selection of photos and give their opinions about fistula definition proposal. (Photos used does not identify patients, they have just typical lesions of LAP)

Typical pictures chosen by the experts will be integrated into the training material issued after 1 internal questionnaire. This support will appear on one page and resume the definitions established by experts with or without the typical pictures.

• Internal Gastroenterology France (about 470 domestic total) will be contacted by email, their department heads have been told that work.

• Internal will inform their characteristics:

• Internal details: name, email address

• Year boarding.

• boarding area.

• Validation IUD (inter-university degree) 1st / 2nd year of proctology.

• Conducting an internal internship in a proctology service?

• Participation in specific courses on the LAP?

• buddy Training on LAP?

• Sending a first questionnaire to internal Google Drive: description pictures of LAP (12 photos lesion initially selected by experts) using checkboxes. Eg ulceration: YES / NO / DO NOT KNOW (Figure 1). The Google Drive platform enables automatic input results in a Microsoft Excel database.

• Draw (using a randomization list EXCEL based on the random function of EXCEL) of 2 groups:

• Group A (training with typical definitions established + photos)

• Group B (only definitions)

• Sending mail to the board of education, different depending on the group, the internal will have as long as they wish

• Sending a second questionnaire with pictures of different LAP those of the first questionnaire. Answers by checkboxes.

• Analysis: a schedule will each questionnaire with a weighting based on the primary / secondary diagnosis. A comparison of pre and post training scores will be performed. And this difference may be calculated between the two groups A and B. In addition, the difficult diagnosis of lesions will be identified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: July 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Internal gastro enterology in France will be contacted by email, their department heads have been warned of this work

Exclusion Criteria:

• Internals who refuses the assessment

Related Conditions & MeSH terms

• Crohn
• Crohn Disease

Intervention

Device:
• Photos + definitions
A broad group of experts (19 proctology and a dermatologist) will be contacted to choose two typical images of LAP (superficial ulceration, deep ulceration ...). 12 photos lesion initially selected by experts.

Other:
• definitions only

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the level (quality) of internal diagnosis of Perianal Lesions of Crohn's Disease Inspection	Assessment the test scores after the training.; The test conssite to evaluate whether training giving the consensus definitions of Crohn's lesions on inspection and typical images of these lesions is effective to enable students to achieve a good level of diagnosis of these lesions acceptable for experts (ideally not significantly different from that of the experts).	within 1 week after training