Clinical Trials Logo
  1. Home
  2. Patient Safety
  3. NCT03663491
  4. Details
NCT03663491 Clinical Trial

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

Patient Safety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663491
Other study ID # Nasal Gastroscopy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date March 31, 2017

Study information
Verified date May 2018
Source University of Leipzig
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of patients safety and comfort in nasal endoscopy.

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.

Recruitment information / eligibility
Status Completed
Enrollment 283
Est. completion date March 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Nasal Gastroscopy
Use of transnasal endoscopes for routine gastroscopy in adults.
• Oral Gastroscopy, unsedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
• Oral Gastroscopy, sedated
Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.
• Oral Gastroscopy with transnasal endoscope, sedated
Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy

Locations
Country Name City State
Germany University of Leipzig Leipzig

Sponsors (1)
Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients satisfaction (pain, discomfort, experience) 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 Pain during the 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
Secondary Previous experience with endoscopy Experience:
Have you had a gastroscopy:
Yes or No
If Yes, how was your gastroscopy:
pleasant
slightly unpleasant
very unpleasant		 Before Endoscopy procedure
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05958108 - Effectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety Phase 3
Not yet recruiting NCT06043895 - EpiFaith CV for Central Venous Catheterization N/A
Recruiting NCT02574104 - Generalizing TESTPILOT to New Single Family Room NICUs N/A
Completed NCT00599209 - Health Information Technology in the Nursing Home N/A
Completed NCT04576299 - Health Care Workers' Perception of Patient Safety During COVID-19 Pandemic
Completed NCT00212927 - Continuity of Care and Outcomes After Discharge From Hospital N/A
Not yet recruiting NCT05062434 - An Intervention to Impact Cardiovascular Implantable Electronic Device Lead Models Implanted in Veterans N/A
Recruiting NCT04861025 - Siderails as a Measure of Physical Restraint. GERBAR Trial
Recruiting NCT04990986 - Co-Development and Evaluation of a Complex Intervention to Increase Medication Safety in Nursing Homes N/A
Recruiting NCT02955836 - Effectiveness of Monitoring Information System of Nursing Related Patient Safety and Quality Indicators N/A
Completed NCT01246544 - Helsinki Declaration on Patient Safety N/A
Recruiting NCT05530187 - ePRO-based Model of Care to Manage and Monitoring Symptoms of Cancer Patients Treated With Immune Checkpoint Inhibitors N/A
Recruiting NCT04176094 - Intensive Care Unit Resident Scheduling Trial N/A
Active, not recruiting NCT05794490 - Learning From Excellence in a Hospital Unit
Recruiting NCT06269250 - Acceptance and Perceived Benefits of Digitalization by Medical Assistants
Recruiting NCT03105713 - Development and Implementation of Patient Safety Checklists Before, During and After In-hospital Surgery N/A
Completed NCT04184570 - Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
Recruiting NCT04897087 - Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event
Active, not recruiting NCT03837912 - Improving Patient Safety in Spanish Primary Care (PC) Centres N/A
Completed NCT00134823 - Improving Pediatric Safety and Quality With Health Care Information Technology N/A