Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Clinical diagnosis; Other: Exclusion diagnosis

• Registration Number: NCT00659763
• Lead Sponsor: Zealand University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-14
• Study First Posted: 2008-04-16
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• age 18-50 years
• consultant in general practice for gastrointestinal symptoms, where the GP suspects irritable bowel syndrome
• full fill the ROME III criteria
• signed informed consent

Exclusion Criteria

• alarm signals
• pregnancy
• comorbid diseases, that interfere with primary endpoint
• medicine and alcohol abuse
• patient do not speak or understand danish
• investigations for irritable bowel syndrome with in the last 3 years

from november 2008: patients aged above 40 with a duration shorter than one year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Clinical diagnosis	Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill he ROME III criteria for IBS
A	Exclusion diagnosis	Patients suspected of irritable bowel syndrome referred from GP´s, who fulfill the ROM III criteria for IBS

Primary Outcome Measures

Name	Time	Method
health related quality of life measured by SF-36	baseline and after 1 year

Secondary Outcome Measures

Name	Time	Method
Symptoms measured by GSRS and GSRS-IBS	baseline, every month for a year and after 1 year
Health related quality of life measured by IBS-QOL measurement	baseline and after 1 year
sick days and reduced productivity measured by WPAI:IBS	baseline, every month 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
differential diagnoses in both arms	1 year

Trial Locations

Locations (1)

Medical Departement, Koege Hospital; 🇩🇰 Køge, Denmark