PRACTA: Computer Tomography (CT) Trial of Acute Abdomen

Sponsor

Kuopio University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00870766

Collaborator

(none)

250

Enrollment

Location

Arms

Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Abdomen	Procedure: Abdominal contrast-enhanced CT scanning	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CT All patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER.	Procedure: Abdominal contrast-enhanced CT scanning Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning
No Intervention: Current practice The patients in the current practice arm are referred to radiological examinations, such as US, plain radiography or CT, based on the clinical need only.

Arm

Intervention/Treatment

Active Comparator: CT

All patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER.

Procedure: Abdominal contrast-enhanced CT scanning

Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning

No Intervention: Current practice

The patients in the current practice arm are referred to radiological examinations, such as US, plain radiography or CT, based on the clinical need only.

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy [at discharge and/or 2-3 mo follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio University Hospital	Kuopio		Finland

Sponsors and Collaborators

Kuopio University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00870766

Other Study ID Numbers:

KUH5200617

First Posted:

Mar 27, 2009

Last Update Posted:

Sep 14, 2010

Last Verified:

Sep 1, 2010

Additional relevant MeSH terms:

Abdomen, Acute

Study Results

No Results Posted as of Sep 14, 2010