HEP-FYN 12-Years Follow-up
Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
1 other identifier
interventional
10,000
0 countries
N/A
Brief Summary
Aims:
- 1.Evaluate the long-term effect of screening and eradication of Helicobacter Pylori on the prevalence of dyspepsia, and, as secondary outcomes, to assess the effect on dyspepsia related health-care consumption and quality of life.
- 2.To investigate symptoms of gastroesophageal reflux (GER), dyspepsia and the combination of these conditions and the effect on quality of life, prognosis and dyspepsia-related health care expenditure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 16, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 20, 2014
November 1, 2014
2.9 years
September 16, 2013
November 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Economic Evaluation
The overall endpoint is expenditure in Danish kroner (on ulcer drugs, upper gastrointestinal endoscopy, GP consultations, hospital admissions related to peptic ulcer). Data on resource consumption of these services and procedures is multiplied with relevant unit prices, from the Danish Medicines Agency and the Danish National Board of Health, to assess a health-cost endpoint.
twelve years
Secondary Outcomes (6)
Frequency of symptoms (dyspepsia, reflux)
twelve years
Drug consumption
Twelve years
Quality of life
twelve years
Incidence of esophagus- and gastric cancer
Twelve years
Upper gastrointestinal endoscopy / X-ray examinations of esophagus and gastric ventricle.
Twelve Years
- +1 more secondary outcomes
Study Arms (2)
Hp-screened group
ACTIVE COMPARATORScreened for Helicobacter Pylori and eradication therapy (1998-99)
Control group
OTHERprimarily unscreened group
Interventions
Eligibility Criteria
You may qualify if:
- Individuals participating in 5 year follow-up
You may not qualify if:
- Individuals not participating in 5 year follow-up
- Moved outside the Region of Southern Denmark or with an unknown address
- Individuals who died
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Region of Southern Denmarkcollaborator
- University of Southern Denmarkcollaborator
Related Publications (1)
Bomme M, Hansen JM, Wildner-Christensen M, Hallas J, Schaffalitzky de Muckadell OB. Effects of Community Screening for Helicobacter pylori: 13-Year Follow-Up Evaluation of a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1715-1723.e7. doi: 10.1016/j.cgh.2017.06.006. Epub 2017 Jun 9.
PMID: 28606845DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 16, 2013
First Posted
December 5, 2013
Study Start
March 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 20, 2014
Record last verified: 2014-11