Assessing the Prevalence of Respiratory Impairment in Chronic Inflammatory Bowel Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 主要终点
- Frequency of functional respiratory signs
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with IBD (Crohn disease or Ulcerative colitis) between January 1990 and December
- •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
排除标准
- •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)
结局指标
主要结局
Frequency of functional respiratory signs
时间窗: Through study completion, an average of 6 months
Frequency of functional respiratory signs (wheezing, dyspnea, coughing, sputum) reported by IBD patients
次要结局
- Drugs(Through study completion, an average of 6 months)
- Exacerbations(Through study completion, an average of 6 months)
- Chronic respiratory diseases(Through study completion, an average of 6 months)