Prevalence of Respiratory Impairment During IBD

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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