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

Study Overview
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Brief Summary
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Evaluation of patients safety and comfort in nasal endoscopy.

Detailed Description
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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.

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

Conditions
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Patient Safety

Intervention / Treatment
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* Procedure: Nasal Gastroscopy
* Procedure: Oral Gastroscopy, unsedated
* Procedure: Oral Gastroscopy, sedated
* Procedure: Oral Gastroscopy with transnasal endoscope, sedated


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unsedated Nasal Gastroscopy<br>Transnasal Endoscopy. No sedation used. Use of local anesthesia. | Procedure: Nasal Gastroscopy<br>* Use of transnasal endoscopes for routine gastroscopy in adults.<br>Procedure: Oral Gastroscopy with transnasal endoscope, sedated<br>* Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy<br>|
| Active Comparator: Oral Gastroscopy, unsedated<br>Transoral Endoscopy. No sedation used. Use of local anesthesia. | Procedure: Oral Gastroscopy, unsedated<br>* Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.<br>|
| Active Comparator: Oral Gastroscopy, sedated<br>Transoral Endoscopy. Intravenous sedation used. | Procedure: Oral Gastroscopy, sedated<br>* Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction (pain, discomfort, experience) | Satisfaction with the procedure: not at all hardly moderately quite extraordinarily (extraordinarily = the best possible outcome, not at all = the worst possible outcome) | During Endoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the 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) | During Endoscopy procedure | 
| Previous experience with endoscopy | Experience: Have you had a gastroscopy: Yes or No If Yes, how was your gastroscopy: pleasant slightly unpleasant very unpleasant | Before Endoscopy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroscopy, Transnasal Endoscopy, Sedation