Ignite Creation Date:
2024-05-06 @ 2:17 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT02001727
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2013-09-16
Brief Title:
HEP-FYN 12-Years Follow-up
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Long-term Effect of Screening and Eradication of Helicobacter Pylori in the General Population - HEP-FYN 12-years Follow-up
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Methods
In 1998-99 20000 individuals age 40-65 years identified by their civil registration number were allocated by a computerized randomized procedure to HP-screening group and control group All participants received a questionnaire at inclusion 1-year and 5-year and now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life In addition we will obtain information from registers on comorbidity use of endoscopies and prescription medication An economic evaluation is done alongside the randomized trial
The primary unscreened group is invited to HP test 13C-urea breath-test in order to analyze the effect of HP-screening according to HP-status
Expected results
The study will provide information on the long-term effect of HP-screening and eradication in a population The study will provide information about the long-term effect on incidence of peptic ulcer in an aging population that is likely to have an increased consumption of ASA and NSAID Furthermore the study will generate knowledge about the long-term prognosis of dyspepsia and reflux in the population dyspepsia and reflux Preliminary results from the 5-yr follow-up 13 showed that is has a great influence on quality of life and the dyspepsia-related health care consumption whether the individual has solely reflux solely dyspepsia or a combination of both symptoms
Long-term follow-up and further analyses of these findings could have great impact on management and treatment of individuals with symptoms It is important to focus on groups in which the symptoms have the greatest influence on quality of life of the individual This finding has not been displayed in other studies
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
Methods
In 1998-99 20000 individuals age 40-65 years identified by their civil registration number were allocated by a computerized randomized procedure to HP-screening group and control group All participants received a questionnaire at inclusion 1-year and 5-year and now again at 12 year follow-up assessing the prevalence of dyspepsia and quality of life In addition we will obtain information from registers on comorbidity use of endoscopies and prescription medication An economic evaluation is done alongside the randomized trial
The primary unscreened group is invited to HP test 13C-urea breath-test in order to analyze the effect of HP-screening according to HP-status
Expected results
The study will provide information on the long-term effect of HP-screening and eradication in a population The study will provide information about the long-term effect on incidence of peptic ulcer in an aging population that is likely to have an increased consumption of ASA and NSAID Furthermore the study will generate knowledge about the long-term prognosis of dyspepsia and reflux in the population dyspepsia and reflux Preliminary results from the 5-yr follow-up 13 showed that is has a great influence on quality of life and the dyspepsia-related health care consumption whether the individual has solely reflux solely dyspepsia or a combination of both symptoms
Long-term follow-up and further analyses of these findings could have great impact on management and treatment of individuals with symptoms It is important to focus on groups in which the symptoms have the greatest influence on quality of life of the individual This finding has not been displayed in other studies
Detailed Description:
Questionnaire
Information on abdominal symptoms GRSR Gastrointestinal symptom rating scale rate of symptoms quality of life SF-36 EQ-5D-5L consumption of ulcer drugs including over the counter drugs hospital admissions dyspepsia-related sick leave days consultations and comorbidity A reminder is sent out 2 weeks after the first contact
Register data
OPED Odense Pharmaca-epidemiological Database Information on reimbursable ulcer drugs ASA NSAID and HP-eradication therapy The Regional Hospital discharge Register Information based on International Classification of Diseases ICD Information on ulcer-related admissions out-patient ulcer diagnosis and comorbidity use of upper gastrointestinal endoscopy
HP-test unscreened group
Invitation of the primary unscreened group to HP test 13C-urea breath-test in order to analyze the effect of HP-screening according to HP-status Instruments automated breath 13Co2 analyser- Isotope ratio mass spectrometer
Almost all persons are infected with HP during childhood Infection with the bacteria in adulthood is rare Only few persons spontaneously turn HP-negative From OPED we will know which individuals who have been prescribed HP-eradication treatment Thus the participants in the control group who are HP-positive at 12-yr follow-up have had the infection the whole period Provided they have not received HP-eradication treatment those who are tested HP-negative have been so the whole period
Information on abdominal symptoms GRSR Gastrointestinal symptom rating scale rate of symptoms quality of life SF-36 EQ-5D-5L consumption of ulcer drugs including over the counter drugs hospital admissions dyspepsia-related sick leave days consultations and comorbidity A reminder is sent out 2 weeks after the first contact
Register data
OPED Odense Pharmaca-epidemiological Database Information on reimbursable ulcer drugs ASA NSAID and HP-eradication therapy The Regional Hospital discharge Register Information based on International Classification of Diseases ICD Information on ulcer-related admissions out-patient ulcer diagnosis and comorbidity use of upper gastrointestinal endoscopy
HP-test unscreened group
Invitation of the primary unscreened group to HP test 13C-urea breath-test in order to analyze the effect of HP-screening according to HP-status Instruments automated breath 13Co2 analyser- Isotope ratio mass spectrometer
Almost all persons are infected with HP during childhood Infection with the bacteria in adulthood is rare Only few persons spontaneously turn HP-negative From OPED we will know which individuals who have been prescribed HP-eradication treatment Thus the participants in the control group who are HP-positive at 12-yr follow-up have had the infection the whole period Provided they have not received HP-eradication treatment those who are tested HP-negative have been so the whole period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None