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

U

University of Leipzig

Status

Completed

Conditions

Patient Safety

Treatments

Procedure: Nasal Gastroscopy
Procedure: Oral Gastroscopy, sedated
Procedure: Oral Gastroscopy, unsedated
Procedure: Oral Gastroscopy with transnasal endoscope, sedated

Study type

Interventional

Funder types

Other

Identifiers

NCT03663491
Nasal Gastroscopy

Details and patient eligibility

About

Evaluation of patients safety and comfort in nasal endoscopy.

Full 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.

Enrollment

283 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

283 participants in 3 patient groups

Unsedated Nasal Gastroscopy
Experimental group
Description:
Transnasal Endoscopy. No sedation used. Use of local anesthesia.
Treatment:
Procedure: Nasal Gastroscopy
Procedure: Oral Gastroscopy with transnasal endoscope, sedated
Oral Gastroscopy, unsedated
Active Comparator group
Description:
Transoral Endoscopy. No sedation used. Use of local anesthesia.
Treatment:
Procedure: Oral Gastroscopy, unsedated
Oral Gastroscopy, sedated
Active Comparator group
Description:
Transoral Endoscopy. Intravenous sedation used.
Treatment:
Procedure: Oral Gastroscopy, sedated

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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