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The hypothesis of the study is that in ulcerative colitis repeated flares of inflammatory activity, as well as mechanisms involved in resolution of the inflammatory response, may contribute to accumulation of damage in the colon leading to functional disturbances and symptoms that affect patient's functioning. The primary objective is to determine whether ulcerative colitis induces permanent anatomical damage, by means of magnetic resonance imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Resonance Imaging | Experimental | A magnetic resonance imaging is perform to detect permanent anatomical damage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | A magnetic resonance imaging is perform to detect permanent anatomical damage. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission | Explorative structural changes | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes on IBDQ-32 questionnaire | Inflammatory bowel diseases health-related quality of life index which is a questionnaire of 32 items, score ranges from 32 to 224. | Baseline |
| Patient reported outcomes on EQ-5D-5L questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia Panes, MD | Contact | 93.227.54.00 | jpanes@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Galdakao | Galdakao | Bizkaia | 48960 | Spain |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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EQ-5D-5L questionnaire a standardized instrument for measuring generic health status, score ranges from -0.224 to 1.
| Baseline |
| Patient reported outcomes on Work Productivity and Activity questionnaire | Work Productivity and Activity Impairment questionnaire is a well validated instrument to measure impairments in work and activities. Consists in 6 questions: question1: yes/no, questions 2 to 4: number of hours (count data), question 5: global rating scale, 0-10 (0 = health problems had no effect on my work, 10 = health problems completely prevented me from working), question 6: global rating scale, 0-10 (0 = health problems had no effect on my daily activities, 10 = health problems completely prevented me from doing my daily activities) | Baseline |
| Patient reported outcomes on Disability Index questionnaire | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time proctitis | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time left colitis | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time extensive colitis | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis | Baseline |
| To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score | Cleveland Clinic Incontinence Score is a questionnaire that reports the consistency and frequency of depositions is a 5 questions questionnaires with 7 possible answers each question. | Baseline |
| Hospital Reina Sofía | Córdoba | Cordoba | 14004 | Spain |
|
| Hospital Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |