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Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging (STRAPPSCORE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Ryhov County Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Medical Research Council of Southeast Sweden
Information provided by:
Ryhov County Hospital
ClinicalTrials.gov Identifier:
NCT00971438
First received: September 1, 2009
Last updated: July 22, 2010
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention
Appendicitis
 Procedure: Diagnostic imaging

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Further study details as provided by Ryhov County Hospital:

Primary Outcome Measures:
  • Proportion of negative appendectomies [ Time Frame: During the hospital admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of unnecessary admissions to hospital [ Time Frame: During the contact with the emergency department ] [ Designated as safety issue: No ]

Estimated Enrollment: 1372
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic imaging
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
Patients with a scoring suggesting an equivocal diagnosis of appendicitis are randomised to diagnostic imaging (CT or US) or repeat examination after inhospital observation
Active Comparator: Repeat examination after observation
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
Patients with a scoring suggesting an equivocal diagnosis of appendicitis are randomised to diagnostic imaging (CT or US) or repeat examination after inhospital observation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women, children <10 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971438

Contacts
Contact: Roland E Andersson, PhD, MD +46-36-321344 roland.andersson@lj.se

Locations
Sweden
Länssjukhuset Ryhov Recruiting
Jönköping, Småland, Sweden, se 551 85
Contact: Roland E Andersson, PhD MD     +46-36-321344     roland.andersson@lj.se    
Principal Investigator: Roland E Andersson, PhD MD            
Sponsors and Collaborators
Ryhov County Hospital
Medical Research Council of Southeast Sweden
Investigators
Principal Investigator: Roland E Andersson, PhD MD Linköping University
  More Information

Publications:

Responsible Party: Roland Andersson, Jönköpings Läns Landsting
ClinicalTrials.gov Identifier: NCT00971438     History of Changes
Other Study ID Numbers: Ryhov County Hospital
Study First Received: September 1, 2009
Last Updated: July 22, 2010
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Ryhov County Hospital:
appendicitis
diagnosis
diagnostic imaging
clinical scoring system

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013