Computer Tomography (CT) Trial of Acute Abdomen

Acute Abdomen Clinical Trial

— PRACTA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870766
• Other study ID #: KUH5200617
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: September 13, 2010
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2010
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18

• abdominal pain > 2h and < 7 days

Exclusion Criteria:

• pregnancy

• acute abdominal trauma

• allergy to iodinated contrast media

• severe renal insufficiency

• metformin medication combined with elevated plasma creatinin level

• lack of cooperation (if informed consent is not possible)

• abdominal pain combined with bleeding shock

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen

Intervention

Procedure:
• Abdominal contrast-enhanced CT scanning
Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy		at discharge and/or 2-3 mo follow-up	No