The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is: \- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies? Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups. Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable gastroscopes from Olympus are used in the reusable group.
Reusable gastroscopes from Olympus are used in the reusable group.
Zealand University Hospital
Køge, Denmark
RECRUITINGTechnical success of single-use gastroscopes vs reusable gastroscopes
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
Complications
Complications to gastroscopy
Time frame: 24 hours and 72 hours follow-up after procedure
30th day mortality
Mortality after 30 days after procedure
Time frame: 30 days
Endoscopist's rating of gastroscope
The endoscopist's rating of the gastroscope
Time frame: Right after procedure
Duration of procedure
The time from intubation of gastroscope until gastroscope removed from esophagus.
Time frame: During the procedure
Time from procedure to discharge
Time from procedure to discharge
Time frame: From procedure to discharge, up to 3 months
Success of specific therapeutic procedures
E.g. success in treating ulcers, banding or stenting
Time frame: During the procedure
Need of new gastroscopy
Need of new gastroscopy during admission
Time frame: During admission, up to 3 months
Readmission
Does the patient need readmission after discharge
Time frame: 30 days after procedure
Sufficient ability to target the biopsy if taken
Successful biopsy which the pathologist can use to either diagnose the patient or to reject a diagnose.
Time frame: During procedure
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