Clinical trial NCT06771102: Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
Official title: Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Disorder
Keywords: Gastroscopy
Upper endoscopy
Gastroscope
Single-use
Reusable
Bedside
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from the indication/decision for early endoscopy to procedure
timeFrame: From indication to procedure, up to two weeks
Secondary outcomes:
measure: Time from indication to the discharge
timeFrame: From indication to discharge, up to 3 months
measure: Time from procedure to discharge
timeFrame: From procedure to discharge, up to 3 months
measure: Duration of the procedure
timeFrame: During the procedure
measure: Did the patient need sedation or local anesthetic throat spray
timeFrame: During the procedure
measure: Technical success
timeFrame: From admission to discharge, up to 3 months
measure: Sufficient ability to target the biopsy if taken
timeFrame: During the procedure
measure: Complications to gastroscopy
timeFrame: 24 and 72 hour follow-up after procedure
measure: 30th day mortality
timeFrame: 30 days
measure: Readmission
timeFrame: 30 days after procedure
measure: The necessity for a new gastroscopy, including the reasons justifying it
timeFrame: During admission, up to 3 months
measure: Endoscopists' rating of the gastroscope
timeFrame: Right after procedure
measure: Learning curve for nurses at the surgical department
timeFrame: During the second period (one year)
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Surgical department of Zealand University Hospital
name: Lasse Bremholm Hansen, PhD, ass.prof
role: STUDY_CHAIR
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