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Cost-Effectiveness of a diagnostic Decision rule for patients with lower Abdominal complaints in primary caRe.

Cost-Effectiveness of a diagnostic Decision rule for patients with lower Abdominal complaints in primary caRe. - The CEDAR-study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37021
Enrollment
990
Registered
2009-04-28
Start date
2009-07-17
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alle organische ziekten van het onderste maagdarmstelsel organic diseases of the lower gut spastic colon (for functional bowel disease)

Interventions

None listed

Sponsors

Zorgonderzoek Nederland (ZON)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with non-acute (> 2 weeks) abdominal complaints originating from the lower GI tract and with at least one of the following criteria (high risk patients): - unexplained rectal blood loss - unexplained weight loss - unexplained abdominal pain - persistant diarrhoea - altered defecation pattern - unexplained fever - sudden onset in elderly patients - abnormal results at physical examination

Exclusion criteria

Exclusion criteria: Being unable to give informed consent Age under 18 years A history of OBD Contra-indications for endoscopy Patients with a positive Triple Faeces Test (TFT-test), a test for detection of intestinal parasites.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the presence of OBD at endoscopy. The diagnostic accuracy of symptoms and signs and the added value of the different tests - notably the calprotectine test- for OBD are quantified. The most cost-effective strategy to discriminate the patients at high risk (requiring a fast track diagnostic workup) from those at low risk (not requiring endoscopy) will be identified.

Secondary

MeasureTime frame
See primary study parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)