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Computer Tomography (CT) Trial of Acute Abdomen (PRACTA)

Primary Purpose

Acute Abdomen

Status

Completed

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Abdominal contrast-enhanced CT scanning

About this trial

This is an interventional diagnostic trial for Acute Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Current practice

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Diagnostic accuracy

Secondary Outcome Measures

Full Information

NCT ID

NCT00870766

First Posted

March 26, 2009

Last Updated

September 13, 2010

Sponsor

Kuopio University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00870766

Brief Title

Computer Tomography (CT) Trial of Acute Abdomen

Acronym

PRACTA

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kuopio University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Abdomen

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Current practice

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Abdominal contrast-enhanced CT scanning

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic accuracy

Time Frame

at discharge and/or 2-3 mo follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Kuopio University Hospital

City

Kuopio

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

Computer Tomography (CT) Trial of Acute Abdomen

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