Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03663491|
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Patient Safety||Procedure: Nasal Gastroscopy Procedure: Oral Gastroscopy, unsedated Procedure: Oral Gastroscopy, sedated Procedure: Oral Gastroscopy with transnasal endoscope, sedated||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||283 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis|
|Actual Study Start Date :||September 1, 2016|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
Experimental: Unsedated Nasal Gastroscopy
Transnasal Endoscopy. No sedation used. Use of local anesthesia.
Procedure: Nasal Gastroscopy
Use of transnasal endoscopes for routine gastroscopy in adults.
Procedure: Oral Gastroscopy with transnasal endoscope, sedated
Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy
Active Comparator: Oral Gastroscopy, unsedated
Transoral Endoscopy. No sedation used. Use of local anesthesia.
Procedure: Oral Gastroscopy, unsedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
Active Comparator: Oral Gastroscopy, sedated
Transoral Endoscopy. Intravenous sedation used.
Procedure: Oral Gastroscopy, sedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.
- Patients satisfaction (pain, discomfort, experience) [ Time Frame: During Endoscopy procedure ]
Satisfaction with the procedure:
- not at all
(extraordinarily = the best possible outcome, not at all = the worst possible outcome)
- Pain during the procedure [ Time Frame: 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)
Yes or No
Numeric Rating Scale 1-10 (1 = no pain, 10 = worst imaginable pain)
- Previous experience with endoscopy [ Time Frame: Before Endoscopy procedure ]
Have you had a gastroscopy:
Yes or No
If Yes, how was your gastroscopy:
- slightly unpleasant
- very unpleasant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663491
|University of Leipzig|
|Leipzig, Germany, 04103|
|Study Chair:||Albrecht Hoffmeister, Prof Dr||University of Leipzig|