NCT00971438

Brief Summary

Patients with acute abdominal pain and suspicion of appendicitis are common. The management of these patients is controversial with large variations between hospitals. The clinical diagnosis is regarded as insufficient necessitating the use of diagnostic techniques like ultrasound, computerized tomography and diagnostic laparoscopy. However, the role of these diagnostic techniques is not clear. This aim of this prospective interventional study is to analyze the impact of the implementation of a clinical score to improve the clinical diagnosis and to serve as a basis for a structured management of these patients by comparison of the results after the implementation of the score with that of a baseline period. In the group of patients with indeterminate diagnosis according to the clinical score, the value of diagnostic imaging will be evaluated and compared with a period of in-hospital observation by randomization. The hypothesis is that a clinical score will decrease the use of unnecessary diagnostic imaging and unnecessary admissions to hospital for observation.

Trial Health

57
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Trial Health Score

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

Enrollment
1,312

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

September 1, 2009

Last Update Submit

May 4, 2015

Conditions

Appendicitis

Keywords

appendicitisdiagnosisdiagnostic imagingclinical scoring system

Outcome Measures

Primary Outcomes (1)

  • Proportion of negative appendectomies

    During the hospital admission

Secondary Outcomes (1)

  • Proportion of unnecessary admissions to hospital

    During the contact with the emergency department

Study Arms (2)

Diagnostic imaging

EXPERIMENTAL

Patients with a scoring suggesting an equivocal diagnosis of acute appendicitis are randomised to either diagnostic imaging (US or CT) or a repeat examination after 4-8 hours in-hospital observation.

Procedure: Diagnostic imaging

Repeat examination after observation

ACTIVE COMPARATOR

Patients with a clinical scoring suggesting an equivocal diagnosis of appendicitis are randomised to either 4-8 hours of in-hospital observation or diagnostic imaging (US or CT)

Procedure: Diagnostic imaging

Interventions

Diagnostic imagingPROCEDURE

Patients with a scoring suggesting an equivocal diagnosis of appendicitis are randomised to diagnostic imaging (CT or US) or repeat examination after inhospital observation

Diagnostic imagingRepeat examination after observation

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients from 10 years of age with \<5 days of abdominal pain and suspicion of appendicitis

You may not qualify if:

  • pregnant women, children \<10 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Länssjukhuset Ryhov

Jönköping, Småland, se 551 85, Sweden

Location

Related Publications (3)

  • Andersson M, Andersson RE. The appendicitis inflammatory response score: a tool for the diagnosis of acute appendicitis that outperforms the Alvarado score. World J Surg. 2008 Aug;32(8):1843-9. doi: 10.1007/s00268-008-9649-y.

    PMID: 18553045BACKGROUND

  • Andersson M, Kolodziej B, Andersson RE. Validation of the Appendicitis Inflammatory Response (AIR) Score. World J Surg. 2021 Jul;45(7):2081-2091. doi: 10.1007/s00268-021-06042-2. Epub 2021 Apr 6.

    PMID: 33825049DERIVED

  • Andersson M, Kolodziej B, Andersson RE; STRAPPSCORE Study Group. Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis. Br J Surg. 2017 Oct;104(11):1451-1461. doi: 10.1002/bjs.10637. Epub 2017 Jul 21.

    PMID: 28730753DERIVED

MeSH Terms

Conditions

AppendicitisDisease

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Roland E Andersson, PhD MD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 3, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

SE(1)