NCT04598256

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 21, 2020

Last Update Submit

October 28, 2020

Conditions

Keywords

endoscopycolonoscopychildrenCovid -19 pandemic

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • The characteristics of patients with Covid-19 infection.

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

    14 days

Study Arms (1)

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

Interventions

Esophagogastroscopy and colonoscopy

Children who underwent endoscopic procedures

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Trh

Izmir, İ̇zmi̇r, 35170, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32303090BACKGROUND
  • 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.

    PMID: 32643767BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • BETÜL AKSOY, MD

    Yes

    STUDY CHAIR
  • YELİZ ÇAĞAN APPAK, MD

    Yes

    STUDY CHAIR
  • DİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR

    Yes

    STUDY CHAIR
  • MAŞALLAH BARAN, PROFESSOR

    Yes

    PRINCIPAL INVESTIGATOR
  • ŞENAY ONBAŞI KARABAĞ, MD

    Yes

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 22, 2020

Study Start

June 1, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

November 2, 2020

Record last verified: 2020-10

Locations