Covid19NCT04598256
Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic
An observational study of Covid19, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Covid19
- What is being tested?
- Endoscopic procedure
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Aug 2020
- How long will I take part?
- 14 Days
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 1 to 18 years who underwent emergency or elective endoscopic procedures will be included in the study. Demographic characteristics of the patients, indication of the procedure, date, place of operation, procedure performed and endoscopic diagnosis will be noted. Before and on the 7th and 14th days after the procedure, patients will be contacted and the symptoms and clinical findings in terms of COVID-19 infection will be questioned and noted. The results of complete blood count, CRP, coagulation profile, COVID-19 PCR, chest radiography and thorax computed tomography will be recorded if it was performed on the patient.
Who may be able to join
- Children between the ages of 1-18 who will undergo endoscopic procedures
- Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure
- Patients who volunteered to study
Who cannot join
- Under 1 year and over 18 years of age
- Patients who could not be questioned about COVID-19 infection before the procedure and on the 7th and 14th days after the procedure
- Patients who not volunteered to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic
Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.
Read the detailed description
Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children. In the investigators' center, which is a pandemic hospital, only emergency endoscopic procedures were performed during the pandemic period, while emergency and elective endoscopic procedures are performed in accordance with the recommendations of the Ministry of Health during the normalization process. Staff and patients in endoscopy units are at risk for COVID-19 infection by inhalation of airborne droplets, conjunctival contact, and potential fecal-oral contamination. In order to reduce the risk of contamination, according to the recommendations of the European Gastrointestinal Endoscopy Association (ESGE); proper cleaning of endoscopic devices, non-reuse of disposable devices, cleaning the endoscopy hall with a disinfectant solution, use of gowns FFP2 / 3 masks and jewelry during the procedure, handwashing with soap and hand disinfection is recommended before and after each procedure. In addition, it is recommended that patients who have undergone endoscopic procedures should be followed up or communicated on days 7 and 14 in terms of the development of COVID-19 infection.
It is recommended that patients should be questioned in terms of COVID-19 infection before endoscopy, but rapid antigen testing and serology are not routinely recommended. Molecular diagnosis (PCR, amplification) tests are recommended for patients at risk for COVID-19 infection.
- Conditions
- Covid19
- Being tested
- Endoscopic procedure
- Keywords
- endoscopy, colonoscopy, children, Covid -19 pandemic
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic procedureProcedure or surgery
Esophagogastroscopy and colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Children who underwent endoscopic procedures | * Children between the ages of 1-18 who were underwent endoscopic procedures
* Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure
* Patients who volunteered to study Receives: Procedure: Endoscopic procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic
The number of participiants who had Covid-19 infection after the endoscopic procedures.
Measured: 14 days
The time of seen covid 19 infection after the endoscopic procedures in participiants.
The developed time of covid 19 infection after the endoscopic procedures in participiants.
Measured: 14 days
The characteristics of patients with Covid-19 infection.
The characteristics of patients with Covid-19 infection after the endoscopic procedures in participiants.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jun 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. masallah Baran, Tepecik Training and Research Hospital
- Investigators
- BETÜL AKSOY, MD, Study chair, YesYELİZ ÇAĞAN APPAK, MD, Study chair, YesDİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR, Study chair, YesMAŞALLAH BARAN, PROFESSOR, Principal investigator, YesŞENAY ONBAŞI KARABAĞ, MD, Study chair, Yes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598256
- Sponsor's protocol ID
- TepecikTRH1
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellise M, Arvanitakis M, Bhandari P, Bisschops R, Van Hooft JE, Kaminski MF, Triantafyllou K, Webster G, Pohl H, Dunkley I, Fehrke B, Gazic M, Gjergek T, Maasen S, Waagenes W, de Pater M, Ponchon T, Siersema PD, Messmann H, Dinis-Ribeiro M. ESGE and ESGENA Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic. Endoscopy. 2020 Jun;52(6):483-490. doi: 10.1055/a-1155-6229. Epub 2020 Apr 17.
PubMed 32303090Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellise M, Arvanitakis M, Bhandari P, Bisschops R, Van Hooft JE, Kaminski MF, Triantafyllou K, Webster G, Voiosu AM, Pohl H, Dunkley I, Fehrke B, Gazic M, Gjergek T, Maasen S, Waagenes W, de Pater M, Ponchon T, Siersema PD, Messmann H, Dinis-Ribeiro M. ESGE and ESGENA Position Statement on gastrointestinal endoscopy and COVID-19: An update on guidance during the post-lockdown phase and selected results from a membership survey. Endoscopy. 2020 Oct;52(10):891-898. doi: 10.1055/a-1213-5761. Epub 2020 Jul 14. No abstract available.
PubMed 32643767
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04598256
- Acronym / sponsor ID
- TepecikTRH1
- Conditions
- Covid19
- Keywords
- endoscopy, colonoscopy, children, Covid -19 pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 22 Oct 2020 (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.
Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.
Detailed description
Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children. In the investigators' center, which is a pandemic hospital, only emergency endoscopic procedures were performed during the pandemic period, while emergency and elective endoscopic procedures are performed in accordance with the recommendations of the Ministry of Health during the normalization process. Staff and patients in endoscopy units are at risk for COVID-19 infection by inhalation of airborne droplets, conjunctival contact, and potential fecal-oral contamination. In order to reduce the risk of contamination, according to the recommendations of the European Gastrointestinal Endoscopy Association (ESGE); proper cleaning of endoscopic devices, non-reuse of disposable devices, cleaning the endoscopy hall with a disinfectant solution, use of gowns FFP2 / 3 masks and jewelry during the procedure, handwashing with soap and hand disinfection is recommended before and after each procedure. In addition, it is recommended that patients who have undergone endoscopic procedures should be followed up or communicated on days 7 and 14 in terms of the development of COVID-19 infection.
It is recommended that patients should be questioned in terms of COVID-19 infection before endoscopy, but rapid antigen testing and serology are not routinely recommended. Molecular diagnosis (PCR, amplification) tests are recommended for patients at risk for COVID-19 infection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children who underwent endoscopic procedures | – | Procedure: Endoscopic procedure* Children between the ages of 1-18 who were underwent endoscopic procedures * Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure * Patients who volunteered to study |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 1 to 18 years who underwent emergency or elective endoscopic procedures will be included in the study. Demographic characteristics of the patients, indication of the procedure, date, place of operation, procedure performed and endoscopic diagnosis will be noted. Before and on the 7th and 14th days after the procedure, patients will be contacted and the symptoms and clinical findings in terms of COVID-19 infection will be questioned and noted. The results of complete blood count, CRP, coagulation profile, COVID-19 PCR, chest radiography and thorax computed tomography will be recorded if it was performed on the patient.
Key inclusion criteria (3 listed)
- Children between the ages of 1-18 who will undergo endoscopic procedures
- Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure
- Patients who volunteered to study
Key exclusion criteria (3 listed)
- Under 1 year and over 18 years of age
- Patients who could not be questioned about COVID-19 infection before the procedure and on the 7th and 14th days after the procedure
- Patients who not volunteered to study
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 |
|---|---|---|
| Endoscopic procedureEsophagogastroscopy and colonoscopy | Procedure or surgery | Children who underwent endoscopic procedures |
Primary outcome
The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic
Time frame: 14 days
The number of participiants who had Covid-19 infection after the endoscopic procedures.
The time of seen covid 19 infection after the endoscopic procedures in participiants.
Time frame: 14 days
The developed time of covid 19 infection after the endoscopic procedures in participiants.
The characteristics of patients with Covid-19 infection.
Time frame: 14 days
The characteristics of patients with Covid-19 infection after the endoscopic procedures in participiants.
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 2 Nov 2020.
- Background: PubMed 32303090Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellise M, Arvanitakis M, Bhandari P, Bisschops R, Van Hooft JE, Kaminski MF, Triantafyllou K, Webster G, Pohl H, Dunkley I, Fehrke B, Gazic M, Gjergek T, Maasen S, Waagenes W, de Pater M, Ponchon T, Siersema PD, Messmann H, Dinis-Ribeiro M. ESGE and ESGENA Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic. Endoscopy. 2020 Jun;52(6):483-490. doi: 10.1055/a-1155-6229. Epub 2020 Apr 17.
- Background: PubMed 32643767Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellise M, Arvanitakis M, Bhandari P, Bisschops R, Van Hooft JE, Kaminski MF, Triantafyllou K, Webster G, Voiosu AM, Pohl H, Dunkley I, Fehrke B, Gazic M, Gjergek T, Maasen S, Waagenes W, de Pater M, Ponchon T, Siersema PD, Messmann H, Dinis-Ribeiro M. ESGE and ESGENA Position Statement on gastrointestinal endoscopy and COVID-19: An update on guidance during the post-lockdown phase and selected results from a membership survey. Endoscopy. 2020 Oct;52(10):891-898. doi: 10.1055/a-1213-5761. Epub 2020 Jul 14. No abstract available.
- PubMed ID: 32303090Link provided by the sponsor.
- PubMed ID: 32643767Link provided by the sponsor.
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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.
BETÜL AKSOY, MD study chair
Yes
YELİZ ÇAĞAN APPAK, MD study chair
Yes
DİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR study chair
Yes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 2 Nov 2020. 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 Turkey (Türkiye). 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?
The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic (time frame: 14 days). The study lists 3 primary outcomes in all. 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 NCT04598256, which also lists 2 linked publications.
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 2 Nov 2020.