Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 7:46 AM
Study NCT ID:
NCT00722995
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2008-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-25', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite criteria of morbid/mortality', 'timeFrame': 'during 18 months and 36 months'}], 'secondaryOutcomes': [{'measure': 'Frequency of morbid events', 'timeFrame': 'during the follow up'}, {'measure': 'Percentage of excess weight loss', 'timeFrame': 'during 18 and 36 months'}, {'measure': 'Frequency of patients having a excess weight loss superior than 50%', 'timeFrame': 'during 36 months'}, {'measure': 'Regression of morbidities', 'timeFrame': 'during 36 months'}, {'measure': 'Rate serum ghrelin', 'timeFrame': 'at inclusion visit, 6, 12, 18 and 36 months'}, {'measure': "Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score", 'timeFrame': 'at inclusion visit, 6, 12, 18 and 36 months'}, {'measure': 'Frequency of morbid/mortality events', 'timeFrame': 'during 36 months'}, {'measure': 'Frequency of patients having excess weight loss superior than 50%', 'timeFrame': 'during 18 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Morbid obesity', 'Sleeve gastrectomy', 'Gastric bypass', 'Complications', 'Efficacity', 'Safety', 'Compare'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass', 'detailedDescription': 'In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 \\>= BMI \\<= 50), a super obesity (BMI \\>50), a super super obesity (BMI\\>60), and obese patients (BMI\\>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.\n\nThis risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged from 18 to 60 years old\n* Patient having given his consent to the use of data from the project\n* Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)\n* Patient presenting one of the following criteria:\n\n * A morbid obesity strict with BMI\\> 40\n * A super obesity BMI\\> 50\n * A super super obesity BMI\\> 60\n * Obese patient in failure following the installation of a gastric banding with BMI\\> 35\n * obese patient 35\\>BMI\\>40 with a comorbidity\n* Preliminary agreement during the consultation of a psychiatrist / psychologist\n\nExclusion Criteria:\n\n* Patient with complications or co morbidities associated involving life to less 6 months\n* Patient presenting no anaesthetic indication\n* Patient presenting no psychiatric indication for obesity surgery\n* Patient not affiliated with a social security scheme\n* Pregnant Patient likely to breastfeed in the first year'}, 'identificationModule': {'nctId': 'NCT00722995', 'acronym': 'SLEEVE', 'briefTitle': 'Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.', 'orgStudyIdInfo': {'id': 'K060213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Sleeve gastrectomy', 'interventionNames': ['Procedure: Sleeve gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Gastric Bypass', 'interventionNames': ['Procedure: Gastric Bypass']}], 'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['SLEEVE'], 'description': 'Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity', 'armGroupLabels': ['1']}, {'name': 'Gastric Bypass', 'type': 'PROCEDURE', 'otherNames': ['BYPASS'], 'description': 'Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93205', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}], 'overallOfficials': [{'name': 'Jean-Marc CATHELINE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}