Clinical Trial: Barrett's Esophagus in Olmsted County

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Population Based Screening for Barrett's Esophagus in Olmsted County : A Pilot Study

Brief Summary:

To compare participation rates in screening for Barrett's Esophagus (BE) using sedated esophagogastroduodenoscopy (EGD), unsedated transnasal endoscopy and capsule endoscopy in a population based cohort. An age and gender stratified random sample of 300 patients from a previously defined (in terms of the presence or absence of symptoms of gastroesophageal reflux using a validated questionnaire) population based cohort from Olmsted County11, 12 using the Rochester Epidemiology Project (REP), who have not undergone endoscopy, will be randomized to undergo screening using capsule endoscopy OR transnasal endoscopy OR conventional sedated endoscopy. The investigators will compare participation rates in the three arms.

To identify factors associated with non-participation in population screening for BE. The investigators will compare demographic and clinical factors in participants and non-participants, to help predict non-participation using data from prior surveys (data has been collected on patient demographics, bowel and reflux symptoms, employment, education, somatization behavior, psychological profiles using the validated Gastroesophageal Reflux questionnaire [GERQ] and the Bowel Disease Questionnaire [BDQ]) which have been completed by all targeted subjects. This preliminary will allow us to identify barriers to screening and develop interventions to increase participation in future larger studies.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: The primary outcome variable for this aim will be the number of subjects in each group that need to be contacted until 20 in each group agree to participate in this study. [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To access variables for prediction of non-participation: age, gender, education level, employment, marital status, esophageal symptoms [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: July 20, 2009
Date Started: January 2009
Date Completion:
Last Updated: January 4, 2012
Last Verified: January 2012