Upper Gastrointestinal Disorder
Conditions
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Esophagogastroduodenoscope, Single-use, Reusable, Bedside
Brief summary
We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy. Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.
Interventions
DEVICEAmbu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable gastroscopes from Olympus are used in the reusable group.
Sponsors
Zealand University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, quality assurance study. Non-randomized, controlled single center feasibility study. Comparing a period where subacute gastroscopies are performed in the endoscopy unit (reusable gastroscopes) with a period where they are performed bedside in the patients room (single-use gastroscopes).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of any gender, 18 years of age or older * Diagnostic EGD without general anaesthesia
Exclusion criteria
* ASA-score of 4 or higher * Unstable patient * Suspicion of active bleeding * Anticoagulants not withheld due to regional guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from the indication/decision for early endoscopy to procedure | From indication to procedure, up to two weeks | — |
| Endoscopists' rating of the gastroscope | Immediately after procedure | The endoscopists' rating of the gastroscope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the procedure | During the procedure | — |
| Did the patient need sedation or local anaesthetic throat spray? | During the procedure | Frequency of use of sedation and/or local anaesthetic throat spray in each group. |
| Technical success | From admission to discharge, up to 3 months | Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines. |
| Time from admission to procedure | From admission to procedure, up to 3 months | — |
| Need for converting to general anaesthesia or reusable gastroscope | During admission, up to 3 months | Did the patient need a new gastroscopy during admission? If so, what is the reason for that, according to the patient's medical record? |
| Findings during the procedure | During the procedure | The frequency of various findings observed during the procedure in each group (e.g., gastric ulcer, varices, stenosis), based on the procedure documentation in the patients' medical records. |
| Complications to gastroscopy | 24 and 72 hour follow-up after procedure | — |
| Time from procedure to discharge | From procedure to discharge, up to 3 months | — |
Countries
Denmark
Outcome results
None listed