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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
Sponsor:
Information provided by (Responsible Party):
University of Leipzig

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Patients satisfaction (pain, discomfort, experience) [ Time Frame: 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 :
  1. 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)

    Gag Reflex:

    Yes or No

    Abdominal pain:

    Numeric Rating Scale 1-10 (1 = no pain, 10 = worst imaginable pain)


  2. Previous experience with endoscopy [ Time Frame: Before Endoscopy procedure ]

    Experience:

    Have you had a gastroscopy:

    Yes or No

    If Yes, how was your gastroscopy:

    • pleasant
    • slightly unpleasant
    • very unpleasant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Germany
University of Leipzig
Leipzig, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Investigators
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Study Chair: Albrecht Hoffmeister, Prof Dr University of Leipzig
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Leipzig
ClinicalTrials.gov Identifier: NCT03663491    
Other Study ID Numbers: Nasal Gastroscopy
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)
Access Criteria: All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Leipzig:
Gastroscopy
Transnasal Endoscopy
Sedation