Dyspepsia Clinical Trial
Official title:
To Scope or Not to Scope: Trial to Reduce Inappropriate Oesophagogastroduodenoscopies for Dyspepsia; a Randomised Controlled Trial
Indigestion or dyspepsia is highly prevalent worldwide. Often these symptoms are of benign
nature and subside without treatment, or with lifestyle interventions like dietary
modifications. Too often, gastroscopy is performed because of dyspepsia. Although this is
indicated when malignancy is suspected, in a substantial part of the cases the gastroscopy is
not indicated and will not achieve clinically relevant results. It is suspected that
gastroscopy is often used for reassurance of patients or as a 'last resort'.
Our hypothesis is that adequate education of patients can replace this need for invasive
measures. The aim of this study was therefore to reduce the volume of gastroscopies for
dyspepsia, by offering patients an e-learning containing educational material on dyspepsia.
During the trial, 119 dyspeptic patients, referred for gastroscopy by the GP, will randomly
be divided into two groups: One group will receive the e-learning instead of gastroscopy
(intervention), the other group will receive the gastroscopy (control).
After a twelve week follow-up, change in symptom severity, disease specific quality of life
and fear of disease will be compared between the two groups.
Rationale: Upper gastrointestinal (GI) symptoms, such as dyspepsia without alarm symptoms,
are highly prevalent in the general population. Lifestyle modifications and medication can
reduce symptoms in most patients. Guidelines state that oesophagogastroduodenoscopy (OGD) is
only indicated in a selected high risk group. In spite of these guidelines, OGD referrals for
dyspepsia without alarm symptoms are still substantial, subjecting patients to unnecessary
risks and causing a burden on healthcare costs and endoscopic capacity. Therefore a strategy
is needed to reduce the volume of OGDs in dyspepsia without alarm symptoms.
Objective: To evaluate the clinical use of a patient-centred, education based, clinical
strategy to reduce the volume of endoscopies for dyspepsia in patients over 18 years of age
without alarm symptoms, referred for OGD through open-access endoscopy compared to usual
care.
Study design: A multicentre, randomised, controlled superiority trial, with two parallel arms
and a primary endpoint of the percentage of patients receiving OGD. Intervention and usual
care will be compared.
Study population: 119 Patients, aged 18 years or above, with upper GI symptoms without alarm
symptoms, referred for open-access OGD.
Intervention: Patients will be offered e-learning instead of endoscopy. The e-learning will
contain educational material and questionnaires. Questionnaire data will be extracted from
the e-learning.
Main study endpoints: The main study endpoint is the difference in proportion of patients
receiving OGD between both arms and Patient Reported Outcomes (PROMS), after a follow-up of
12 weeks.
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