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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03663491
Enrollment
283
Registered
2018-09-10
Start date
2016-09-01
Completion date
2017-03-31
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Safety

Keywords

Gastroscopy, Transnasal Endoscopy, Sedation

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.

Interventions

PROCEDURENasal Gastroscopy

Use of transnasal endoscopes for routine gastroscopy in adults.

PROCEDUREOral Gastroscopy, unsedated

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

PROCEDUREOral Gastroscopy, sedated

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

PROCEDUREOral Gastroscopy with transnasal endoscope, sedated

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

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Patients satisfaction (pain, discomfort, experience)During Endoscopy procedureSatisfaction with the procedure: * not at all * hardly * moderately * quite * extraordinarily (extraordinarily = the best possible outcome, not at all = the worst possible outcome)

Secondary

MeasureTime frameDescription
Pain during the procedureDuring Endoscopy procedureNose 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)
Previous experience with endoscopyBefore Endoscopy procedureExperience: Have you had a gastroscopy: Yes or No If Yes, how was your gastroscopy: * pleasant * slightly unpleasant * very unpleasant

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026