Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 6:37 PM
Study NCT ID:
NCT06884800
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of recurrence', 'timeFrame': '1 year postoperatively', 'description': 'Incidence of recurrence will be recorded'}], 'secondaryOutcomes': [{'measure': 'Incidence of anatomical failure', 'timeFrame': '1 year postoperatively', 'description': 'Incidence of anatomical failure will be recorded'}, {'measure': 'Incidence of complications', 'timeFrame': '1 year postoperatively', 'description': 'Incidence of complications such as dysphagia, chest pain on eating, gas-bloat, postprandial fullness, restriction in belching, and increased flatus will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Toupet Fundoplication', 'Radiological Negative', 'Endoscope', 'Hiatal Hernia']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the feasibility and effectiveness of laparoscopic toupet fundoplication (LTF) for treating gastroesophageal reflux disease (GERD) symptoms and disease-specific Quality of Life (QoL).', 'detailedDescription': 'Heartburn, regurgitation, dysphagia, and chest pain are regarded as common esophageal symptoms of gastroesophageal reflux disease (GERD). On the other hand, there are very few reports of laryngopharyngeal reflux (LPR), which is associated with persistent upper airway contact, acidic and non-acidic reflux, and aerosol that results in posterior laryngitis, edema, and glottis erythema.\n\nProton-pump inhibitor (PPI) therapy, Laparoscopic Nissen Fundoplication (LNF), and Laparoscopic Toupet Fundoplication (LTF) have been proven to be effective for the treatment of GERD. However, the therapeutic management of patients with hiatal hernia is debated and treatment remains empirical. Previous studies on PPI therapy and LNF had been published with promising but controversial results. Therefore, the role of LTF is even less explored and evidence is scarce'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age above 18 years old.\n* Both sexes.\n* Hiatal hernia patients (Hill's grade III \\& IV) by endoscopy and negative by radiology indicated for Toupet fundoplication.\n\nExclusion Criteria:\n\n* Recurrent patients.\n* Age above 70 years old\n* Unfit for surgery"}, 'identificationModule': {'nctId': 'NCT06884800', 'briefTitle': "Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients", 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': "Laparoscopic Toupet's Fundoplication: Is it Proper Solution of Radiological Negative, Endoscopically Positive Hiatal Hernia Patients", 'orgStudyIdInfo': {'id': '1241/08/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laparoscopic toupet fundoplication group', 'description': 'Patients will undergo laparoscopic toupet fundoplication.', 'interventionNames': ['Procedure: Laparoscopic toupet fundoplication']}], 'interventions': [{'name': 'Laparoscopic toupet fundoplication', 'type': 'PROCEDURE', 'description': 'Patients will undergo laparoscopic toupet fundoplication.', 'armGroupLabels': ['Laparoscopic toupet fundoplication group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61611', 'city': 'Minya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahman M Salah, MD', 'role': 'CONTACT', 'email': 'Abdelrahman.salah@mu.edu.eg', 'phone': '00201064746493'}], 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Abdelrahman M Salah, MD', 'role': 'CONTACT', 'email': 'Abdelrahman.salah@mu.edu.eg', 'phone': '00201064746493'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.', 'investigatorFullName': 'Abdelrahman Mohamed Salah', 'investigatorAffiliation': 'Minia University'}}}}