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CrohnPhotoCrohnNCT02842450

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

An observational study of Crohn, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Crohn
What is being tested?
Photos + definitions and definitions only
Type of treatment
Medical device
How many people
249 participants
Where
1 siteFrance
Study dates
30 Jun 2016to 31 Jul 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Internal gastro enterology in France (about 470 domestic total) will be contacted by email, their department heads have been warned of this work

Who may be able to join

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

Who cannot join

  • Internals who refuses the assessment

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

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.

Read the detailed 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.
Conditions
Crohn
Being tested
Photos + definitions, definitions only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photos + definitionsDevice

    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.

  • definitions onlyOther

Study groups in NCT02842450
Study groupRoleWhat they receive
training with typical definitions established + photosA 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.
Receives: Device: Photos + definitions
Training only with definitionsInterns will receive typical definitions of LAP stages
Receives: Other: definitions only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: within 1 week after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2016 (estimated)
  2. Study start30 Jun 2016
  3. Primary completion31 May 2017
  4. Study completion31 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02842450
Sponsor's protocol ID
PhotoCrohn
Acronym
PhotoCrohn
Status last verified
Sep 2017
First submitted
13 Jul 2016
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the level (quality) of internal diagnosis of Perianal Lesions of Crohn's Disease Inspection (time frame: within 1 week after training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.

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