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

NCT ID: NCT03663491

Last Updated: 2019-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-03-31

Brief Summary

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Evaluation of patients safety and comfort in nasal endoscopy.

Detailed Description

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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.

Conditions

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Patient Safety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Unsedated Nasal Gastroscopy

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

Group Type EXPERIMENTAL

Nasal Gastroscopy

Intervention Type PROCEDURE

Use of transnasal endoscopes for routine gastroscopy in adults.

Oral Gastroscopy with transnasal endoscope, sedated

Intervention Type PROCEDURE

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

Oral Gastroscopy, unsedated

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

Group Type ACTIVE_COMPARATOR

Oral Gastroscopy, unsedated

Intervention Type PROCEDURE

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

Oral Gastroscopy, sedated

Transoral Endoscopy. Intravenous sedation used.

Group Type ACTIVE_COMPARATOR

Oral Gastroscopy, sedated

Intervention Type PROCEDURE

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

Interventions

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Nasal Gastroscopy

Use of transnasal endoscopes for routine gastroscopy in adults.

Intervention Type PROCEDURE

Oral Gastroscopy, unsedated

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

Intervention Type PROCEDURE

Oral Gastroscopy, sedated

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

Intervention Type PROCEDURE

Oral Gastroscopy with transnasal endoscope, sedated

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albrecht Hoffmeister, Prof Dr

Role: STUDY_CHAIR

University of Leipzig

Locations

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University of Leipzig

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Schuldt AL, Kirsten H, Tuennemann J, Heindl M, van Bommel F, Feisthammel J, Hollenbach M, Hoffmeister A. Necessity of transnasal gastroscopy in routine diagnostics: a patient-centred requirement analysis. BMJ Open Gastroenterol. 2019 Apr 14;6(1):e000264. doi: 10.1136/bmjgast-2018-000264. eCollection 2019.

Reference Type DERIVED
PMID: 31139423 (View on PubMed)

Other Identifiers

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Nasal Gastroscopy

Identifier Type: -

Identifier Source: org_study_id

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