Brief Title
Prevalence of Respiratory Impairment During IBD
Official Title
Assessing the Prevalence of Respiratory Impairment in Chronic Inflammatory Bowel Diseases
Brief Summary
Patients will be recruited during a routine consultation with a physician in the
hepato-gastroenterology department.
At the end of the consultation, patients will have to complete the following questionnaire:
"European Community Respiratory Health Survey" which allows the screening of patients at risk
of chronic respiratory diseases (asthma, COPD, bronchiectasis, emphysema).
In the event of a declaration of functional respiratory signs, a consultation with a
pulmonologist will be systematically proposed. At the end of this consultation, if the doctor
deems it necessary, further investigations will be proposed and/or regular follow-up
organised.
The main objective of this study is to estimate the prevalence of respiratory symptoms
leading to a diagnosis of chronic respiratory disease in patients with inflammatory bowel
diseases (IBD) (Crohn's disease and UC).
The main criterion for judgement will be the frequency of functional respiratory signs
(wheezing, dyspnea, cough, sputum) reported by IBD patients through an adapted self-report
questionnaire.
Detailed Description
Approximately one-third of IBD patients will develop systemic extra-digestive manifestations
(joint, dermatologic or ophthalmologic) during the course of their disease and up to 25% will
develop these systemic manifestations even before the diagnosis of IBD. Among these systemic
affections, respiratory manifestations remain poorly known because they are not searched for
in daily clinical practice.
The main objective of this study is to estimate the prevalence of respiratory symptoms
leading to a diagnosis of chronic respiratory disease (asthma, COPD, bronchiectasis) in
patients with IBD (Crohn's disease and UC).
Patients will be recruited during a routine consultation with a physician in the
hepato-gastroenterology department as part of the management of their chronic inflammatory
bowel disease.
During this consultation, the investigating physician will explain to the patient the
objective of the study and check with him/her the eligibility criteria. The patient will then
be given an information note. He or she may ask any questions he or she wishes and if he or
she refuses to participate in the study, he or she will have to sign an objection form in
duplicate (one copy will be given to the patient and the other will be kept in the medical
file). The doctor will also sign these two copies.
At the end of the consultation, patients will have to complete the following questionnaire:
"European Community Respiratory Health Survey" which allows the screening of patients at risk
of chronic respiratory diseases (asthma, COPD, bronchiectasis, emphysema).
In the event of a declaration of functional respiratory signs, a consultation with a
pulmonologist from the Department of Pulmonology of the CHRU Nancy-Brabois will be
systematically proposed. At the end of this consultation, if the doctor deems it necessary,
further investigations will be proposed and/or regular follow-up organised. Patients will be
informed of this potential follow-up in pneumology before the questionnaire is given. There
is no change in the usual follow-up of the population in case of non-reporting of functional
respiratory signs.
The main criterion for judgement will be the frequency of functional respiratory signs
(wheezing, dyspnea, cough, sputum) reported by IBD patients through an adapted self-report
questionnaire.
If our hypothesis is confirmed, this will have direct practical consequences on the global
and multidisciplinary management of IBD patients, in particular through a systematic search
for chronic respiratory disease, which is currently under-researched in these patients.
This will improve the quality of life as well as the morbidity and mortality of our patients.
Study Type
Observational
Primary Outcome
Frequency of functional respiratory signs
Secondary Outcome
Chronic respiratory diseases
Condition
Chronic Obstructive Pulmonary Disease
Intervention
Pulmonology consultation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
480
Start Date
May 1, 2020
Completion Date
August 2020
Primary Completion Date
July 2020
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with IBD (Crohn disease or Ulcerative colitis) between January 1990 and
December 2019.
- Consultation in the Hepato-Gastroenterology Department of the CHRU Nancy-Brabois
- Patients who received full information about the research organization and did not
object to the use of the data.
- Patients over 18 years of age
Exclusion Criteria:
- Inability to complete the questionnaire
- Diagnosis of IBD uncertain
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health
Code :Pregnant, parturient or breastfeeding mother, Minor person, person who is
subject to a legal protection measure
- Unable to express consent
- Persons deprived of their liberty by a judicial or administrative decision,
- Persons under psychiatric care (articles L. 3212-1 and L. 3213-1)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +33.83.15.70.24, [email protected]
Administrative Informations
NCT ID
NCT04225650
Organization ID
2019PI164
Responsible Party
Sponsor
Study Sponsor
Central Hospital, Nancy, France
Collaborators
University of Lorraine
Study Sponsor
, ,
Verification Date
December 2019