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| Name | Class |
|---|---|
| Statens Serum Institut | OTHER |
| University of Copenhagen | OTHER |
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The purpose of this study is to determine whether a clinical diagnosis of irritable bowel syndrome based on patient reported symptoms and a few blood tests is safe, and to determine whether a clinical diagnosis is as good for the patient and as economical for the society as a diagnosis based on exclusion of a number of organic diseases by performing a number of blood tests, fecal analyzes and a scopic examination of bowel.
The purpose of the second part of the study is to determine which intestinal parasites the patients have in their bowel and whether these parasites are the cause of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS |
| |
| B | Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exclusion diagnosis | Other | Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test. 3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| health related quality of life measured by SF-36 | baseline and after 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms measured by GSRS and GSRS-IBS | baseline, every month for a year and after 1 year | |
| sick days and reduced productivity measured by WPAI:IBS | baseline, every month and after 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
from november 2008: patients aged above 40 with a duration shorter than one year
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Patients are recruited from primary care.
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| Name | Affiliation | Role |
|---|---|---|
| Anne Line OE Engsbro, MD | Køge Hospital | Principal Investigator |
| Peter Bytzer, Professor MD | Køge Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Departement, Koege Hospital | Køge | 4600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33029843 | Derived | Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7. | |
| 24495890 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood and fecal sample
|
| Clinical diagnosis | Other | Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP. |
|
| differential diagnoses in both arms |
| 1 year |
| Health related quality of life measured by IBS-QOL measurement | baseline and after 1 year |
| The overall satisfaction with the diagnostic strategy | after initial diagnostic work up and after 1 year |
| The use of resources in the health care system measured by the number of doctor visits, ambulatory visits, emergency room visits, hospitalizations and diagnostic tests over 1 year follow up. | every month and after 1 year |
| Larsen AR, Engsbro AL, Bytzer P. Screening instruments for anxiety and depression in patients with irritable bowel syndrome are ambiguous. Dan Med J. 2014 Feb;61(2):A4785. |
| 23357491 | Derived | Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26. |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |