Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06842602
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D002182', 'term': 'Candy'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric volume', 'timeFrame': 'baseline', 'description': 'No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .'}, {'measure': 'Gastric pH measurements', 'timeFrame': 'baseline', 'description': 'No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.'}], 'secondaryOutcomes': [{'measure': 'endoscopist satisfaction', 'timeFrame': 'baseline', 'description': 'At the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)'}, {'measure': 'general procedure satisfaction', 'timeFrame': 'baseline', 'description': 'Before discharge, general procedure satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product effects (1=increase in hunger, 2=increase in thirst, 3=increase in dyspepsia, 4=abstained, 5= decrease in hunger, 6= decrease in thirst, 7= decrease in dyspepsia)'}, {'measure': 'Complication', 'timeFrame': 'Perioperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric pH', 'gastric residual volume', 'gastroscopy', 'candy', 'gum', 'preoperative fasting rules'], 'conditions': ['Gastroscopy']}, 'descriptionModule': {'briefSummary': 'Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (\\<2.5) values are shown to be determinants in the occurrence of pulmonary complications .', 'detailedDescription': 'The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III,\n* oriented\n* cooperative\n* scheduled for elective gastroscopy\n\nExclusion Criteria:\n\n* body mass index is (BMI) \\>30 kg/m2,\n* full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),\n* patients with diabetes\n* patients with who underwent bowel cleansing\n* patients who did not want to give consent to participate'}, 'identificationModule': {'nctId': 'NCT06842602', 'briefTitle': 'Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients Using Chewing Gum and Candy: Prospective Randomized Double-Blind Study', 'orgStudyIdInfo': {'id': '2023/07-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group control', 'description': 'strict fasting rules', 'interventionNames': ['Other: strict fasting rules']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group gum', 'description': 'chewed gum within 2 hours before the procedure', 'interventionNames': ['Other: gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group candy', 'description': 'consumed candy within 2 hours before the procedure', 'interventionNames': ['Other: candy']}], 'interventions': [{'name': 'gum', 'type': 'OTHER', 'description': 'chewed gum within 2 hours before the procedure', 'armGroupLabels': ['Group gum']}, {'name': 'candy', 'type': 'OTHER', 'description': 'consumed candy within 2 hours before the procedure', 'armGroupLabels': ['Group candy']}, {'name': 'strict fasting rules', 'type': 'OTHER', 'description': 'followed strict fasting rules', 'armGroupLabels': ['Group control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16400', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Mehmet Fatih Erol', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Mehmet fatih erol, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek ıhtısas tra'}, {'name': 'Füsun gözen, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bursa Yuksek Ihtısas tranin and research hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'm.d', 'investigatorFullName': 'Mehmet Fatih Erol', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}