Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:26 AM
Study NCT ID:
NCT04454112
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2020-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring', 'timeFrame': '2 month', 'description': 'NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.'}], 'secondaryOutcomes': [{'measure': 'Pre and post-gastrostomy evaluation of gastroesophageal reflux in children using 24-hour pH monitoring', 'timeFrame': '7 month', 'description': 'NI patients who had previously received pre and post-gastrostomy (Group 1) or gastrostomy+NF (Group 2) were underwent pH monitoring pre-post operatively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate 24-hour pH monitoring results before and after gastrostomy in neurological impaired (NI) children who underwent gastrostomy or Nissen fundoplication (NF) concurrently with gastrostomy.', 'detailedDescription': 'Gastrointestinal (GI) problems causing malnutrition may develop quite frequently in patients with neuromotor developmental delay. Diagnosis of GERD in patients with neurological impairment (NI) might be more difficult due to the absence of characteristic features in many cases. One of the best methods for the diagnosis of GER is the 24-hour esophageal pH monitoring.Even though there are some statements in the literature advocating that gastroesophageal reflux may develop in the late period in patients undergoing only gastrostomy, there are also reports supporting that gastrostomy does not contribute to the development of reflux.Regardless of whether the patient received anti-reflux surgery or not, the long-term follow-up is necessary in patients feeding with gastrostomy.The aim of this study is to compare the results of pre- and postoperative 24-hour pH monitoring in patients who underwent gastrostomy only and who underwent fundoplication concurrently with gastrostomy and to evaluate influence of gastrostomy/ LNF+ gastrostomy on GER.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of neurological damage Must be able to apply gastrostomy or Nissen fundoplication concurrently with gastrostomy.\n\nexclusion Criteria: to use anti-reflux medications long period of time gastroesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT04454112', 'briefTitle': 'Pre and Post-gastrostomy Evaluation of GER in Children Using 24-hour pH Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Pre and Post-gastrostomy Evaluation of Gastroesophageal Reflux in Children Using 24-hour pH Monitoring', 'orgStudyIdInfo': {'id': '2019/192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24-hour esophageal pH monitoring', 'description': '24-hour esophageal pH monitoring was conducted using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands). This system consists of a portable data logger (MMS Investigation and Diagnostic Software®) and a disposable catheter which contains two pH electrodes (Unisensor, Attikon, Switzerland). Before recording, the pH electrode was calibrated in the special buffer solutions at pH values of 1 and 2.', 'interventionNames': ['Device: 24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).']}], 'interventions': [{'name': '24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).', 'type': 'DEVICE', 'description': '24-hour esophageal pH monitoring application', 'armGroupLabels': ['24-hour esophageal pH monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200/', 'city': 'Kurupelit', 'state': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition,', 'geoPoint': {'lat': 41.3532, 'lon': 36.19299}}], 'overallOfficials': [{'name': 'Berat Dilek Demirel', 'role': 'STUDY_CHAIR', 'affiliation': 'she underwent gastrostomy to patients with neurological damage'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatma Demirbaş', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor of Pediatric Gastroenterology', 'investigatorFullName': 'Fatma Demirbaş', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}