Early Esophagogastroduodenoscopy Performed Bedside Using Single-use Disposable Endoscope

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Disorder

• Registration Number: NCT07033286
• Lead Sponsor: Zealand University Hospital

Brief Summary

We aim to evaluate whether the use of single-use gastroscopes at the bedside can reduce the time from clinical indication to procedure compared to reusable gastroscopes used in the endoscopy unit for patients referred for subacute gastroscopy.

Participants in the first period will be scheduled for gastroscopy with a reusable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the hospital department (bed-side) with a single-use gastroscope.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-05
• Primary Completion: 2024-06-13
• Study Completion: 2024-07-13
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Patients of any gender, 18 years of age or older
• Diagnostic EGD without general anaesthesia

Exclusion Criteria

• ASA-score of 4 or higher
• Unstable patient
• Suspicion of active bleeding
• Anticoagulants not withheld due to regional guidelines

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
Endoscopists' rating of the gastroscope	Immediately after procedure	The endoscopists' rating of the gastroscope

Secondary Outcome Measures

Name	Time	Method
Time from admission to procedure	From admission to procedure, 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 anaesthetic throat spray?	During the procedure	Frequency of use of sedation and/or local anaesthetic throat spray in each group.
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.
Complications to gastroscopy	24 and 72 hour follow-up after procedure
Need for converting to general anaesthesia or reusable gastroscope	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?
Findings during the procedure	During the procedure	The frequency of various findings observed during the procedure in each group (e.g., gastric ulcer, varices, stenosis), based on the procedure documentation in the patients' medical records.

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark