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'To scope or not to scope' - Reducing oesophagoduodenoscopies for uncomplicated dyspepsia: a randomised controlled trial

'To scope or not to scope' - Reducing oesophagoduodenoscopies for uncomplicated dyspepsia: a randomised controlled trial - Reducing oesophagoduodenoscopies for uncomplicated dyspepsia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47304
Enrollment
414
Registered
2017-06-27
Start date
2017-10-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia gastric complaints

Interventions

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.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients are eligible for inclusion when they meet the following criteria at randomisation: - Age *18 years - Reported upper gastrointestinal symptoms in the past 6 months - Referred for OGD - Guidelines for referral not met - Signed informed consent

Exclusion criteria

Exclusion criteria: Patient who fulfil the criteria for OGD acoording to the Dutch college of General Practitioners (NHG) guidelines ('Maagklachten') and NICE guidelines on *Upper gastrointestinal tract cancers*.;- Family history of gastric- or oesophageal cancer (at least one first or second grade family member with a malignancy at the age of 50 or younger) - Diseases or circumstances that will most likely impair understanding of the e-learning - Any argument provided by a patient*s own GP stating the urge of OGD, notwithstanding the guidelines

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the difference between the two study arms in proportion of patients receiving direct OGD after the initial visit to the endoscopy clinic, out of the total number of patients referred for open-access endoscopy. OGDs performed at any time in the study after initial successful intervention , will still be considered successful intervention (intention-to-treat).

Secondary

MeasureTime frame
The difference between the change scores of the two study arms on the following three parameters: Health-related anxiety, severity of upper GI symptoms and quality of life. These will be assessed using a questionnaire at the initial visit to the endoscopy clinic and after 8 weeks The proportion of patients that received the e-learning and nevertheless received OGD in the 8 weeks after the initial visit, out of the total number of patients receiving the e-learning Educational value of the e-learning. This will be tested through a knowledge test integrated in the e-learning and administered before and after the e-learning

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)