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NCT03663491 Clinical Trial

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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663491
Other study ID # Nasal Gastroscopy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date March 31, 2017

Study information
Verified date May 2018
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of patients safety and comfort in nasal endoscopy.

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.

Recruitment information / eligibility
Status Completed
Enrollment 283
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Nasal Gastroscopy
Use of transnasal endoscopes for routine gastroscopy in adults.
• Oral Gastroscopy, unsedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
• Oral Gastroscopy, sedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.
• Oral Gastroscopy with transnasal endoscope, sedated
Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy

Locations
Country Name City State
Germany University of Leipzig Leipzig

Sponsors (1)
Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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