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

Not yet recruiting

• Conditions: Upper Gastrointestinal Disorder

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

Brief Summary

The goal of this clinical trial is to investigate whether gastroscopies with single-use gastroscopes used bedside can reduce the time from indication to procedure compared with gastroscopies with reusable gastroscopes used in the endoscopy unit in patients referred to a subacute gastroscopy. The main question it aims to answer is:

- Is the time from indication to procedure reduced when performing the gastroscopy bedside compared with performing the gastroscopy in the endoscopy unit.

Researchers will compare bedside gastroscopies with gastrosopies in the endoscopy unit to see if the time from indication to procedure is reduced.

Participants will in the first period have gastroscopy with a reusable gastroscope in the endoscopy unit. In the second period participants will have gastroscopy with a single-use gastroscope bedside.

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

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

Inclusion Criteria

• Patients of any gender, 18 years of age or older admitted to surgical department 2 (the acute section of the surgical department) 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
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 mounths
Duration of the procedure	During the procedure
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 which the pathologist can use to either diagnose the patient or to reject a diagnose.
Complications to gastroscopy	24 and 72 hour follow-up after procedure
30th day mortality	30 days
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
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)

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Køge, Denmark