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

Sponsor
Tepecik Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04598256
Collaborator
(none)
77
1
3
25.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic procedure

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
77 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic [14 days]

    The number of participiants who had Covid-19 infection after the endoscopic procedures.

  2. The time of seen covid 19 infection after the endoscopic procedures in participiants. [14 days]

    The developed time of covid 19 infection after the endoscopic procedures in participiants.

  3. The characteristics of patients with Covid-19 infection. [14 days]

    The characteristics of patients with Covid-19 infection after the endoscopic procedures in participiants.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tepecik Trh İzmir İ̇zmi̇r Turkey 35170

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Prof. masallah Baran, professor, Tepecik Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04598256
Other Study ID Numbers:
  • TepecikTRH1
First Posted:
Oct 22, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. masallah Baran, professor, Tepecik Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2020