Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-01 @ 5:07 PM
Study NCT ID:
NCT04598256
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic', 'timeFrame': '14 days', 'description': 'The number of participiants who had Covid-19 infection after the endoscopic procedures.'}, {'measure': 'The time of seen covid 19 infection after the endoscopic procedures in participiants.', 'timeFrame': '14 days', 'description': 'The developed time of covid 19 infection after the endoscopic procedures in participiants.'}, {'measure': 'The characteristics of patients with Covid-19 infection.', 'timeFrame': '14 days', 'description': 'The characteristics of patients with Covid-19 infection after the endoscopic procedures in participiants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopy', 'colonoscopy', 'children', 'Covid -19 pandemic'], 'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '32303090', 'type': 'BACKGROUND', 'citation': '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': '32643767', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.esge.com/esge-and-esgena-position-statement-on-gastrointestinal-endoscopy-and-the-covid-19-pandemic/', 'label': 'PubMed ID: 32303090'}, {'url': 'https://www.esge.com/update-on-esge-and-esgena-position-statement-on-gastrointestinal-endoscopy-and-covid-19/', 'label': 'PubMed ID: 32643767'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.', 'detailedDescription': "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.\n\nIt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages of 1-18 who will undergo endoscopic procedures\n* Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure\n* Patients who volunteered to study\n\nExclusion Criteria:\n\n* Under 1 year and over 18 years of age\n* Patients who could not be questioned about COVID-19 infection before the procedure and on the 7th and 14th days after the procedure\n* Patients who not volunteered to study'}, 'identificationModule': {'nctId': 'NCT04598256', 'briefTitle': 'Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Tepecik Training and Research Hospital'}, 'officialTitle': 'Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic', 'orgStudyIdInfo': {'id': 'TepecikTRH1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children who underwent endoscopic procedures', 'description': '* Children between the ages of 1-18 who were underwent endoscopic procedures\n* Patients who can be questioned about COVID-19 infection before and on the 7th and 14th days after the procedure\n* Patients who volunteered to study', 'interventionNames': ['Procedure: Endoscopic procedure']}], 'interventions': [{'name': 'Endoscopic procedure', 'type': 'PROCEDURE', 'description': 'Esophagogastroscopy and colonoscopy', 'armGroupLabels': ['Children who underwent endoscopic procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35170', 'city': 'Izmir', 'state': 'İ̇zmi̇r', 'country': 'Turkey (Türkiye)', 'facility': 'Tepecik Trh', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'BETÜL AKSOY, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yes'}, {'name': 'YELİZ ÇAĞAN APPAK, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yes'}, {'name': 'DİLEK YILMAZ ÇİFTDOĞAN, PROFESSOR', 'role': 'STUDY_CHAIR', 'affiliation': 'Yes'}, {'name': 'MAŞALLAH BARAN, PROFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yes'}, {'name': 'ŞENAY ONBAŞI KARABAĞ, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tepecik Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Prof. masallah Baran', 'investigatorAffiliation': 'Tepecik Training and Research Hospital'}}}}