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OpenTrials
Completed

NCT Number: NCT03663491

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

Evaluation of patients safety and comfort in nasal endoscopy.

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Key information

Conditions

Patient Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Leipzig

Leipzig, 04103, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nasal Gastroscopy

Procedure

Use of transnasal endoscopes for routine gastroscopy in adults.

Oral Gastroscopy, unsedated

Procedure

Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.

Oral Gastroscopy, sedated

Procedure

Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.

Oral Gastroscopy with transnasal endoscope, sedated

Procedure

Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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