Evaluation of Transnasal Endoscopy During COVID-19 Pandemic

Not Applicable

• Conditions: Endoscopy
• Interventions: Other: gastroscopy in transnasal techique

• Registration Number: NCT04734912
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is submitted to the patient.

Detailed Description

COVID-19 is transmitted, among other things, by a droplet infection. Conventional gastroscopy through the patient's mouth is therefore considered a high-risk examination for the medical and nursing staff. Alternatively, gastroscopy can also be performed through the patient's nose. An advantage here is that the aerosol formation is naturally significantly reduced and the patient usually does not need sedation, since in transnasal endoscopy no stranglehold occurs. Transnasal endoscopy therefore appears to us, especially during the COVID-19 pandemic, as a safe alternative to conventional gastroscopy.

Patients who received the indication for endoscopic diagnostics using gastroscopy in transnasal technique will be included into the study. The examination is carried out in standard technique and is not influenced by the study. Following the examination, patient data is collected pseudonymously and a questionnaire is sumbitted to the patient.

Only patients who have the indication for gastroscopy in transnasal technique are included. A specific risk to patients cannot be foreseen.This study does not interfere with diagnostics or therapy.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-13
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-30
• Last Update Submitted: 2021-01-30
• Study First Posted: 2021-02-02
• Last Update Posted: 2021-02-02
• Primary Completion: 2021-06-15
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Indication for transnasal endoscopy

Exclusion Criteria

• pregnancy
• breast feeding
• contraindication to transnasal endoscopy
• pronounced blood clotting disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gastroscopy in transnasal technique	gastroscopy in transnasal techique	All patients with indication for gastroscopy in transnasal techqiue are included.

Primary Outcome Measures

Name	Time	Method
Questionnaire	after examination, about 15 minutes	a questionnaire with 5 questions regarding the quality of the examination, technique and safety is presented to the patients

Trial Locations

Locations (1)

University Hospital Mainz; 🇩🇪 Mainz, Rhenanie-Palatinate, Germany