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

October 28, 2020 updated by: Prof. masallah Baran, Tepecik Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İ̇zmi̇r
      • İzmir, İ̇zmi̇r, Turkey, 35170
        • Tepecik Trh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Endoscopic procedure
Esophagogastroscopy and colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tepecik Training and Research Hospital

Investigators

  • Study Chair: BETÜL AKSOY, MD, yes
  • Study Chair: YELİZ ÇAĞAN APPAK, MD, yes
  • Study Chair: DİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR, yes
  • Principal Investigator: MAŞALLAH BARAN, PROFESSOR, yes
  • Study Chair: ŞENAY ONBAŞI KARABAĞ, MD, yes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 2, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TepecikTRH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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