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

May 20, 2019 updated by: University of Leipzig
Evaluation of patients safety and comfort in nasal endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

283

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unsedated Nasal Gastroscopy
Transnasal Endoscopy. No sedation used. Use of local anesthesia.
Procedure: Nasal Gastroscopy
Use of transnasal endoscopes for routine gastroscopy in adults.
Procedure: Oral Gastroscopy with transnasal endoscope, sedated
Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy
Active Comparator: Oral Gastroscopy, unsedated
Transoral Endoscopy. No sedation used. Use of local anesthesia.
Procedure: Oral Gastroscopy, unsedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
Active Comparator: Oral Gastroscopy, sedated
Transoral Endoscopy. Intravenous sedation used.
Procedure: Oral Gastroscopy, sedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During Endoscopy procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During Endoscopy procedure
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
Before Endoscopy procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Study Chair: Albrecht Hoffmeister, Prof Dr, University of Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 10, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Nasal Gastroscopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

IPD Sharing Time Frame

All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

IPD Sharing Access Criteria

All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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