Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis

Not Applicable

Completed

• Conditions: Patient Safety
• Interventions: Procedure: Oral Gastroscopy, unsedated; Procedure: Oral Gastroscopy, sedated; Procedure: Nasal Gastroscopy; Procedure: Oral Gastroscopy with transnasal endoscope, sedated

• Registration Number: NCT03663491
• Lead Sponsor: University of Leipzig

Brief Summary

Evaluation of patients safety and comfort in nasal endoscopy.

Detailed Description

Introduction: Numerous indications require regular outpatient upper gastrointestinal endoscopy (EGD). In most cases, peroral gastroscopy is performed. The aim of this study was to evaluate the necessity and outpatients' demand for transnasal gastroscopy (nEGD).

Methods: A questionnaire was used to assess patients' choice of method, previous experience, psychological and sociodemographic data. Furthermore, the patients' satisfaction with and potentially perceived discomfort during the examination as well as their preference for a method with regard to future examinations was evaluated.

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-05
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-10
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 283

Inclusion Criteria

• Informed consent
• Adequate knowledge of oral and written german

Exclusion Criteria

• Inpatient Treatment
• For medical reasons (narrow nasal cavity, band ligation of esophageal varices, Placement of a percutaneous endoscopic gastrostomy, planned colonoscopy under sedation the same day, abnormal coagulation, emergency procedures)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unsedated Nasal Gastroscopy	Oral Gastroscopy with transnasal endoscope, sedated	Transnasal Endoscopy. No sedation used. Use of local anesthesia.
Oral Gastroscopy, unsedated	Oral Gastroscopy, unsedated	Transoral Endoscopy. No sedation used. Use of local anesthesia.
Oral Gastroscopy, sedated	Oral Gastroscopy, sedated	Transoral Endoscopy. Intravenous sedation used.
Unsedated Nasal Gastroscopy	Nasal Gastroscopy	Transnasal Endoscopy. No sedation used. Use of local anesthesia.

Primary Outcome Measures

Name	Time	Method
Patients satisfaction (pain, discomfort, experience)	During Endoscopy procedure	Satisfaction with the procedure: * not at all; * hardly; * moderately; * quite; * extraordinarily; (extraordinarily = the best possible outcome, not at all = the worst possible outcome)

Secondary Outcome Measures

Name	Time	Method
Previous experience with endoscopy	Before Endoscopy procedure	Experience: Have you had a gastroscopy: Yes or No; If Yes, how was your gastroscopy: * pleasant; * slightly unpleasant; * very unpleasant
Pain during the procedure	During Endoscopy procedure	Nose pain Numeric Rating Scale 1-10 (1 = no pain, 10 = worst imaginable pain); Throat pain Numeric Rating Scale 1-10 (1 = no pain, 10 = worst imaginable pain); Gag Reflex: Yes or No; Abdominal pain: Numeric Rating Scale 1-10 (1 = no pain, 10 = worst imaginable pain)

Trial Locations

Locations (1)

University of Leipzig; 🇩🇪 Leipzig, Germany