Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients

Not Applicable

Recruiting

• Conditions: Upper Gastrointestinal Disorder

• Registration Number: NCT06771102
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study Start: 2025-01-13
• Study First Posted: 2025-01-13
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-15
• Primary Completion: 2027-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time from the indication/decision for early endoscopy to procedure	From indication to procedure, up to two weeks

Secondary Outcome Measures

Name	Time	Method
Duration of the procedure	During the procedure
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
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
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.
30th day mortality	30 days

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark