Upper Gastrointestinal Disorder
Conditions
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable, Bedside
Brief summary
The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy. Participants in the first period will be scheduled for gastroscopy with a re-usable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the ward (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 admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia.
Exclusion criteria
* ASA-score of 4 or higher * Unstable patient * Suspicion of ventricular retention * Suspicion of active bleeders * Need for expert endoscopist to perform the procedure, e.g. stenting * Patients \< 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from the indication/decision for early endoscopy to procedure | From indication to procedure, up to two weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from indication to the discharge | From indication to discharge, up to 3 months | — |
| Time from procedure to discharge | From procedure to discharge, up to 3 months | — |
| Duration of the procedure | During the procedure | — |
| Did the patient need sedation or local anesthetic throat spray | During the procedure | — |
| 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. |
| Sufficient ability to target the biopsy if taken | During the procedure | Successful biopsy that provides the pathologist with sufficient material to either confirm or rule out a diagnosis. If the biopsy is inadequate, the pathologist will note this in the report. |
| Complications to gastroscopy | 24 and 72 hour follow-up after procedure | — |
| 30th day mortality | 30 days | — |
| Readmission | 30 days after procedure | Does the patient need readmission after discharge? |
| The necessity for a new gastroscopy, including the reasons justifying it | 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? |
| Endoscopists' rating of the gastroscope | Right after procedure | The endoscopist's rating of the gastroscope |
| Learning curve for nurses at the surgical department | During the second period (one year) | Following each procedure, the nurses will complete a short questionnaire evaluating their level of comfort (from 1-5) during the various steps of the procedure. |
Countries
Denmark
Contacts
CONTACTCamilla Kjelkvist-Born, MD
CONTACTMarie Louise Malmstrøm, MD, PhD
STUDY_CHAIRLasse Bremholm Hansen, PhD, ass.prof
Surgical department of Zealand University Hospital
Outcome results
None listed