Patient SafetyNCT03663491
Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis
A study testing Nasal Gastroscopy, Oral Gastroscopy, unsedated and Oral Gastroscopy, sedated in people with Patient Safety, run by University of Leipzig at 1 site in Germany.
Trial summary
Evaluation of patients safety and comfort in nasal endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Safety
- What is being tested?
- Nasal Gastroscopy, Oral Gastroscopy, unsedated and Oral Gastroscopy, sedated
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Adequate knowledge of oral and written german
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Evaluation of patients safety and comfort in nasal endoscopy.
Read the 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.
- Conditions
- Patient Safety
- Being tested
- Nasal Gastroscopy, Oral Gastroscopy, unsedated, Oral Gastroscopy, sedated, Oral Gastroscopy with transnasal endoscope, sedated
- Keywords
- Gastroscopy, Transnasal Endoscopy, Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal GastroscopyProcedure or surgery
Use of transnasal endoscopes for routine gastroscopy in adults.
Oral Gastroscopy, unsedatedProcedure or surgery
Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
Oral Gastroscopy, sedatedProcedure or surgery
Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.
Oral Gastroscopy with transnasal endoscope, sedatedProcedure or surgery
Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| Unsedated Nasal Gastroscopy | Experimental | Transnasal Endoscopy. No sedation used. Use of local anesthesia. Receives: Procedure: Nasal Gastroscopy; Procedure: Oral Gastroscopy with transnasal endoscope, sedated |
| Oral Gastroscopy, unsedated | Active comparator | Transoral Endoscopy. No sedation used. Use of local anesthesia. Receives: Procedure: Oral Gastroscopy, unsedated |
| Oral Gastroscopy, sedated | Active comparator | Transoral Endoscopy. Intravenous sedation used. Receives: Procedure: Oral Gastroscopy, sedated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During Endoscopy procedure
Secondary outcomes (2)
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)
Measured: During Endoscopy procedure
Previous experience with endoscopy
Experience:
Have you had a gastroscopy:
Yes or No
If Yes, how was your gastroscopy:
- pleasant
- slightly unpleasant
- very unpleasant
Measured: Before Endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Sep 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albrecht Hoffmeister, Prof Dr, Study chair, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663491
- Sponsor's protocol ID
- Nasal Gastroscopy
- Status last verified
- May 2018
- First submitted
- 21 Jun 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)
Publications
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.
PubMed 31139423
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of Transnasal Gastroscopy in Routine Diagnostics - a Patient Centered Requirement Analysis
- ClinicalTrials.gov ID
- NCT03663491
- Acronym / sponsor ID
- Nasal Gastroscopy
- Conditions
- Patient Safety
- Keywords
- Gastroscopy, Transnasal Endoscopy, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unsedated Nasal Gastroscopy | Experimental | Procedure: Nasal Gastroscopy, Procedure: Oral Gastroscopy with transnasal endoscope, sedatedTransnasal Endoscopy. No sedation used. Use of local anesthesia. |
| Oral Gastroscopy, unsedated | Active comparator | Procedure: Oral Gastroscopy, unsedatedTransoral Endoscopy. No sedation used. Use of local anesthesia. |
| Oral Gastroscopy, sedated | Active comparator | Procedure: Oral Gastroscopy, sedatedTransoral Endoscopy. Intravenous sedation used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- Adequate knowledge of oral and written german
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal GastroscopyUse of transnasal endoscopes for routine gastroscopy in adults. | Procedure or surgery | Unsedated Nasal Gastroscopy |
| Oral Gastroscopy, unsedatedUse of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia. | Procedure or surgery | Oral Gastroscopy, unsedated |
| Oral Gastroscopy, sedatedUse of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation. | Procedure or surgery | Oral Gastroscopy, sedated |
| Oral Gastroscopy with transnasal endoscope, sedatedUse of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy | Procedure or surgery | Unsedated Nasal Gastroscopy |
Primary outcome
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)
2 secondary outcomes
Pain during the procedure
Time frame: During Endoscopy procedure
Previous experience with endoscopy
Time frame: Before Endoscopy procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Derived from this study: PubMed 31139423Schuldt 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.
- Individual participant dataSharing planned: Yes. All data will be available to other researchers on request. (Mail to juergen.feisthammel@medizin.uni-leipzig.de)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albrecht Hoffmeister, Prof Dr study chair
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Gastroscopy, Oral Gastroscopy, unsedated and Oral Gastroscopy, sedated in people with Patient Safety, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients satisfaction (pain, discomfort, experience) (time frame: During Endoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03663491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.