NCT02842450

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

July 13, 2016

Last Update Submit

September 7, 2017

Conditions

Outcome Measures

Primary Outcomes (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).

    within 1 week after training

Study Arms (2)

training with typical definitions established + photos

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.

Device: Photos + definitions

Training only with definitions

Interns will receive typical definitions of LAP stages

Other: definitions only

Interventions

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.

training with typical definitions established + photos
Training only with definitions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

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

You may not qualify if:

  • Internals who refuses the assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • DE PARADES Vincent, MD

    Groupe Hospitalier Paris Saint-Joseph (FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 22, 2016

Study Start

June 30, 2016

Primary Completion

May 31, 2017

Study Completion

July 31, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations