Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT02218957
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Pouch Roux-en-Y Gastric Bypass Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': '2 years', 'description': 'Complications will be divided in short-term complications (within 30 days after operation) and long-term complications (after 30 days). All adverse event will be registered.'}, {'measure': 'Quality of life', 'timeFrame': '2 years', 'description': 'The quality of life will be assessed by using the BAROS.'}], 'primaryOutcomes': [{'measure': 'Weight reduction', 'timeFrame': '2 years', 'description': 'Excess weight loss (%EWL)'}], 'secondaryOutcomes': [{'measure': 'Change in comorbidities', 'timeFrame': '2 years', 'description': 'Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:\n\n1. comorbidity resolved\n2. comorbidity improved\n3. comorbidity unchanged\n4. comorbidity worsened\n\nThis will be done for diabetes mellitus, hypertension, dyslipidemia and OSAS.'}, {'measure': 'Change in comorbidities', 'timeFrame': '2 years', 'description': 'Preoperatively the number of patients with comorbidities will be calculated. At two year follow-up this will be calculated again. Patients will be divided in groups:\n\n1. comorbidity resolved\n2. comorbidity improved\n3. comorbidity unchanged\n4. comorbidity worsened\n\nThis will be done for diabetes mellitus, hypertension, dislipidemia and OSAS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Roux-en-Y Gastric Bypass'], 'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': "Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.\n\nThe objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.\n\nThe study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient eligible for bariatric surgery according Fried guidelines\n\nPrimary Gastric bypass\n\n* BMI 35 - 40 with a comorbidity\n* or BMI \\> 40\n\nExclusion Criteria:\n\n* Exclusion criteria for bariatric surgery (Fried Guidelines)\n* Patients with language problems that interveins to follow medical advises\n* Genetic diseases that intervens to follow medical advises\n* Chronic bowel diseases\n* Nephrologic (MDRD \\<30) of liver diseases (AST/ALT more than twice the norm)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02218957', 'briefTitle': 'Extended Pouch Roux-en-Y Gastric Bypass Study', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Restrictive Extended Pouch in Roux-en-Y Gastric Bypass: a Prospective Randomized Control Trial', 'orgStudyIdInfo': {'id': 'ExtPouch'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard RYGB', 'description': 'Standard RYGB', 'interventionNames': ['Procedure: Standard RYGB']}, {'type': 'EXPERIMENTAL', 'label': 'Extended Pouch RYGB', 'description': 'Restrictive/extended pouch RYGB', 'interventionNames': ['Procedure: Extended Pouch RYGB']}], 'interventions': [{'name': 'Extended Pouch RYGB', 'type': 'PROCEDURE', 'armGroupLabels': ['Extended Pouch RYGB']}, {'name': 'Standard RYGB', 'type': 'PROCEDURE', 'armGroupLabels': ['Standard RYGB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800WC', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'overallOfficials': [{'name': 'Jens Homan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital Arnhem'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}