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Clinical Trials/NCT03663491
NCT03663491CompletedNot Applicable

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

University of Leipzig2 sites in 1 country283 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
283
Locations
2
Primary Endpoint
Patients satisfaction (pain, discomfort, experience)

Study Overview

Brief Summary

Evaluation of patients safety and comfort in nasal endoscopy.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Unsedated Nasal Gastroscopy

Experimental

Transnasal Endoscopy. No sedation used. Use of local anesthesia.

Intervention: Nasal Gastroscopy (Procedure)

Unsedated Nasal Gastroscopy

Experimental

Transnasal Endoscopy. No sedation used. Use of local anesthesia.

Intervention: Oral Gastroscopy with transnasal endoscope, sedated (Procedure)

Oral Gastroscopy, unsedated

Active Comparator

Transoral Endoscopy. No sedation used. Use of local anesthesia.

Intervention: Oral Gastroscopy, unsedated (Procedure)

Oral Gastroscopy, sedated

Active Comparator

Transoral Endoscopy. Intravenous sedation used.

Intervention: Oral Gastroscopy, sedated (Procedure)

Outcomes

Primary Outcomes

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

  • Previous experience with endoscopy(Before Endoscopy procedure)
  • Pain during the procedure(During Endoscopy procedure)

Investigators

Sponsor
University of Leipzig
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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