Description of Perianal Lesions in a Cohort of Crohn's Disease Patients

NCT02899013 | Completed

• 1 other identifier: LAPCROHN
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The perianal lesions (LAP) specific for Crohn's disease have been reported in 1938, six years after the first cases of luminal disease. If phenotypic data of the latter are well documented today, those of perianal disease remain inadequately described. The reasons are numerous: understated symptoms by patients, elementary semiotics proctology ignored by practitioners, lack of validated classifications to track these violations and challenges to undertake clinical trials to high standard of proof in view of these variables, etc. ... Moreover, the impact of these LAP varies across studies (10-80%). in addition to the above-mentioned reasons, these results are also due to the different definitions of LAP used in the studies, their collection in reference centers versus tertiary centers, their potential occurrence at any time of disease progression, their greater frequency in case of distal disease (12% for infringement isolated ileal, 15% in breach ileo colic, 41% in case of colonic involvement and 91% in case of rectal involvement). Yet the specific LAP should be better documented because they are a factor of poor prognosis of Crohn's disease.

Conditions

Crohn Disease

Keywords

Perianal Lesions

Outcome Measures

Primary Outcomes (1)

• Assessment of PDAI Score

  activity profile of specific LAP (PDAI score of Irvine)

  Day 15

Secondary Outcomes (4)

• Assessment of Wexner score

  Day 15

• Assessment of phenotypic profile of the luminal disease (classification of Montreal)

  Day 15

• Assessment of Harvey-Bradshaw Index

  Day 15

• Assessment of quality of life by GIQLI questionary

  Day 15

Interventions

No intervention OTHER

Observational study to describe Perianal Lesions in a Cohort of Crohn's Disease Patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Crohn's disease diagnosed patients, all confused phenotype

You may qualify if:

• Crohn's disease diagnosed, all confused phenotype
• Perianal reached whatever its phenotype (specific or non-Crohn's disease).

You may not qualify if:

• Refusal or inability of the patient to be eventually reached by telephone
• Psychiatric pathology and / or non-understanding of the French language making the collection of random data

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

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

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

FR (1)