Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-27 @ 11:03 AM
Study NCT ID:
NCT06155851
Status:
UNKNOWN
Last Update Posted:
2023-12-05
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}], 'ancestors': [{'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005773', 'term': 'Gastroscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-11-24', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.', 'timeFrame': 'prospective cohort syudy_ up to 1 year', 'description': 'To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiatus Hernia']}, 'referencesModule': {'references': [{'pmid': '219227', 'type': 'BACKGROUND', 'citation': "Levin JG, Seidman JG. Selective packaging of host tRNA's by murine leukemia virus particles does not require genomic RNA. J Virol. 1979 Jan;29(1):328-35. doi: 10.1128/JVI.29.1.328-335.1979."}, {'pmid': '254272', 'type': 'BACKGROUND', 'citation': 'Daraz B, Piela A. [Treatment and prevention of EPH-gestosis]. Pieleg Polozna. 1978;(5):7-8. No abstract available. Polish.'}, {'pmid': '7280', 'type': 'BACKGROUND', 'citation': 'Kromer W, Freundt KJ. [In vitro inhibition of oxidative N-demethylation with carbon disulfide]. Arzneimittelforschung. 1976 Feb;26(2):189-94. German.'}, {'pmid': '2756', 'type': 'BACKGROUND', 'citation': 'Newton JM, Razzo RN. Proceedings: The influence of formulation variables on the in vitro release of drug from hard gelatin capsules. J Pharm Pharmacol. 1975 Dec;27 Suppl?-2:79P. No abstract available.'}, {'pmid': '107121', 'type': 'BACKGROUND', 'citation': 'Herold G, Stephan B, Menzel T. [The behavior of bioelements during long-term parenteral feeding]. Infusionsther Klin Ernahr. 1979 Apr;6(2):105-10. German.'}]}, 'descriptionModule': {'briefSummary': 'To study the prevalence of hiatus hernia in GERD patients underwent upper endoscopy To study the effect of hiatus hernia on the severity of GERD symptoms.', 'detailedDescription': 'Gastro-esophageal reflux disease (GERD) is a common problem for which patients seek care from a broad array of primary care providers, medical sub-specialists, and surgeons.\n\nIt is estimated that 10 to 20 percent of people in Western countries have GERD, when defined as heartburn or regurgitation at least once a week. (Chapelle, et al. 2021)\n\nThe practice guidelines for GERD recommend diagnostic testing in the presence of alarm symptoms, which include dysphagia, odynophagia, weight loss, gastrointestinal bleeding, and anemia.\n\nA detailed history of the pattern, severity, and duration of alarm symptoms is essential. (Katz, et al., 2022) Hiatus hernia refers to condition in which elements of the abdominal cavity, most commonly the stomach, herniate through the esophageal hiatus into the mediastinum.\n\nHiatus hernia is a frequent finding during upper gastrointestinal endoscopy. Type I hiatal hernia is the sliding hiatal hernia, which accounts for more than 95% of all hiatal hernias with the remaining 5% being Para-esophageal hiatus hernias (Kotekar, et al 2021)\n\nEndoscopy is a common diagnostic tool in the evaluation of patients with upper gastrointestinal pathology, specifically gastroesophageal reflux disease (GERD) and hiatal hernia.\n\nThe relationship between these two disease processes are relatively intertwined and have clinical significance given the fact patients with hiatal hernia may be more likely to have acid reflux and there is a close relationship with hiatal hernia size and incidence of reflux disease. (Gomaa, et al 2022) Worldwide, it is believed that the relation between hiatus hernia and gastro-esophageal reflux disease (GERD) have varied considerably.\n\nIn our locality the prevalence of hiatal hernia in GERD patients and the effect of hiatal hernia on the severity of GERD symptoms is unknown.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all cases matching inclusion criteria during the time of the study will be enrolled', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years or older, Patients with GERD symptoms who don't respond to PPI therapy (8 weeks ) or cases with alarm symptoms (dysphagia, anemia ,vomiting , weight loss , GI bleeding , onset of symptoms in old age ,..etc)\n\nExclusion Criteria:\n\n* Complete PPI responder. Patient with any contraindication for endoscopy . Refusal of participation"}, 'identificationModule': {'nctId': 'NCT06155851', 'briefTitle': 'Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence of Hiatus Hernia in Gastro-Esophageal Reflux Disease Patients Underwent Upper Endoscopy', 'orgStudyIdInfo': {'id': 'Prevalence of Hiatus Hernia in'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Upper Endoscopy', 'type': 'PROCEDURE', 'description': 'Endescopy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa Ibrahim abo el ela, Resident', 'role': 'CONTACT', 'email': 'asoraibrahim8@gmail.com', 'phone': '01096265575'}, {'name': 'Mohamed Omar Abdelmalek, Prof', 'role': 'CONTACT', 'phone': '01007343214'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Esraa Ibrahim Aboelela', 'investigatorAffiliation': 'Assiut University'}}}}