NCT00870766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1 year

First QC Date

March 26, 2009

Last Update Submit

September 13, 2010

Conditions

Acute Abdomen

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

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

Study Arms (2)

CT

ACTIVE COMPARATOR

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

Procedure: Abdominal contrast-enhanced CT scanning

Current practice

NO INTERVENTION

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.

Interventions

Abdominal contrast-enhanced CT scanningPROCEDURE

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

CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18
  • abdominal pain \> 2h and \< 7 days

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

FI(1)