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Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic

NCT ID: NCT04598256

Last Updated: 2020-11-02

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

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-08-31

Brief Summary

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Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.

Detailed Description

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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

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Covid19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Endoscopic procedure

Intervention Type PROCEDURE

Esophagogastroscopy and colonoscopy

Interventions

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Endoscopic procedure

Esophagogastroscopy and colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tepecik Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prof. masallah Baran

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BETÜL AKSOY, MD

Role: STUDY_CHAIR

Yes

YELİZ ÇAĞAN APPAK, MD

Role: STUDY_CHAIR

Yes

DİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR

Role: STUDY_CHAIR

Yes

MAŞALLAH BARAN, PROFESSOR

Role: PRINCIPAL_INVESTIGATOR

Yes

ŞENAY ONBAŞI KARABAĞ, MD

Role: STUDY_CHAIR

Yes

Locations

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Tepecik Trh

Izmir, İ̇zmi̇r, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32303090 (View on PubMed)

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, 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.

Reference Type BACKGROUND
PMID: 32643767 (View on PubMed)

Related Links

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https://www.esge.com/esge-and-esgena-position-statement-on-gastrointestinal-endoscopy-and-the-covid-19-pandemic/

PubMed ID: 32303090

https://www.esge.com/update-on-esge-and-esgena-position-statement-on-gastrointestinal-endoscopy-and-covid-19/

PubMed ID: 32643767

Other Identifiers

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TepecikTRH1

Identifier Type: -

Identifier Source: org_study_id