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

Covid19 Clinical Trial

Official title:

Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598256
• Other study ID #: TepecikTRH1
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Procedure:
• Endoscopic procedure
Esophagogastroscopy and colonoscopy

Locations

Country	Name	City	State
Turkey	Tepecik Trh	Izmir	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellisè 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. — View Citation

Gralnek IM, Hassan C, Beilenhoff U, Antonelli G, Ebigbo A, Pellisé 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 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Primary	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.	14 days
Primary	The characteristics of patients with Covid-19 infection.	The characteristics of patients with Covid-19 infection after the endoscopic procedures in participiants.	14 days

External Links

•   PubMed ID: 32303090
•   PubMed ID: 32643767