Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-03 @ 6:32 AM
Study NCT ID:
NCT02012894
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-10', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in DeMeester's score", 'timeFrame': 'baseline, 24 months after LSG', 'description': 'Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in lower esophageal sphincter pressure', 'timeFrame': 'baseline, 24 months after LSG', 'description': 'Esophageal manometry measures several parameters including lower esophageal sphincter pressure'}, {'measure': 'Change from baseline in amplitude of esophageal peristaltic waves', 'timeFrame': 'baseline, 24 months after LSG', 'description': 'Esophageal manometry evaluates quality and amplitude of esophageal peristalsis'}, {'measure': 'Change from baseline in grade of esophagitis', 'timeFrame': 'baseline, 24 months after LSG', 'description': 'Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis'}, {'measure': 'Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score', 'timeFrame': 'Baseline, 24 months after LSG', 'description': 'Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'Gastroesophageal reflux', 'sleeve gastrectomy', 'pH-monitoring', 'manometry'], 'conditions': ['Gastroesophageal Reflux', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '23232995', 'type': 'BACKGROUND', 'citation': 'Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.'}, {'pmid': '22065341', 'type': 'BACKGROUND', 'citation': 'Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.'}, {'pmid': '23460263', 'type': 'BACKGROUND', 'citation': 'Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.'}, {'pmid': '25379861', 'type': 'DERIVED', 'citation': 'Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.'}]}, 'descriptionModule': {'briefSummary': 'Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.\n\nThe aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.', 'detailedDescription': 'Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive morbidly obese patients selected for LSG', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of obesity exceeding 5 years\n* documented previous weight loss attempts,\n* body mass index (BMI)) of 40-50 kg/m2\n* age of 18-60 years.\n\nExclusion Criteria:\n\n* contraindications to pneumoperitoneum\n* large esophageal hiatal hernia\n* pregnancy,\n* drug or alcohol abuse,\n* psychological disorders (e.g., bulimia, depression)\n* hormonal or genetic obesity-related disease,\n* previous gastric surgery'}, 'identificationModule': {'nctId': 'NCT02012894', 'briefTitle': 'Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'RGEOB/76'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese patients with preoperative GER', 'description': 'Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A)'}, {'label': 'Obese patients without preoperative GER', 'description': 'Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'state': 'Turin', 'country': 'Italy', 'facility': 'University of Turin', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Fabrizio Rebecchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fabrizio Rebecchi', 'investigatorAffiliation': 'University of Turin, Italy'}}}}