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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable gastroscopes from Olympus are used in the reusable group.
Zealand University Hospital
Køge, Denmark
RECRUITINGTime from the indication/decision for early endoscopy to procedure
Time frame: From indication to procedure, up to two weeks
Time from indication to the discharge
Time frame: From indication to discharge, up to 3 months
Time from procedure to discharge
Time frame: From procedure to discharge, up to 3 months
Duration of the procedure
Time frame: During the procedure
Did the patient need sedation or local anesthetic throat spray
Time frame: During the procedure
Technical success
Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines.
Time frame: From admission to discharge, up to 3 months
Sufficient ability to target the biopsy if taken
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.
Time frame: During the procedure
Complications to gastroscopy
Time frame: 24 and 72 hour follow-up after procedure
30th day mortality
Time frame: 30 days
Readmission
Does the patient need readmission after discharge?
Time frame: 30 days after procedure
The necessity for a new gastroscopy, including the reasons justifying it
Did the patient need a new gastroscopy during admission? If so, what is the reason for that, according to the patient's medical record?
Time frame: During admission, up to 3 months
Endoscopists' rating of the gastroscope
The endoscopist's rating of the gastroscope
Time frame: Right after procedure
Learning curve for nurses at the surgical department
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.
Time frame: During the second period (one year)
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