Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-26 @ 6:23 PM
Study NCT ID:
NCT03673969
Status:
WITHDRAWN
Last Update Posted:
2019-07-26
First Post:
2018-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mini Gastric Bypass vs Roux enY Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participant will not know the arm prior to surgery, but will be made aware of it afterward'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding to progress the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excess weight loss', 'timeFrame': '2 years post surgery', 'description': 'Amount of weight lost'}], 'secondaryOutcomes': [{'measure': 'Type 2 diabetes remission', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Type 2 diabetes remission'}, {'measure': 'Morbidity', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Morbidity'}, {'measure': 'Mortality', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Mortality'}, {'measure': 'Operative time', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Operative time'}, {'measure': 'Length of stay', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Length of stay'}, {'measure': 'Readmission rate', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Readmission rate'}, {'measure': 'Lipid profile', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Lipid profile'}, {'measure': 'Malnutrition', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Malnutrition'}, {'measure': 'Liver failure', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Liver failure'}, {'measure': 'Gastro-oesophageal reflux', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Gastro-oesophageal reflux'}, {'measure': 'Upper GI cancer', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Upper GI cancer'}, {'measure': 'Diarrhoea', 'timeFrame': '6 months, 2 years, 5 years and 10 years', 'description': 'Diarrhoea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mini Gastric Bypass', 'Roux En-Y Gastric Bypass', 'Bariatric surgery', 'Type 2 diabetes'], 'conditions': ['Gastric Bypass']}, 'descriptionModule': {'briefSummary': 'The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK', 'detailedDescription': 'The main aim of this project is to develop an ideal bariatric/metabolic surgery operation.\n\nThe ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients.\n\nMini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK.\n\nNo previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight.\n* All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss.\n* The person has been receiving or will receive intensive management in a tier 3 service.\n* The person is generally fit for anaesthesia and surgery.\n* The person commits to the need for long-term follow-up\n\nExclusion Criteria:\n\n* Not meeting the eligibility criteria\n* Under 18s'}, 'identificationModule': {'nctId': 'NCT03673969', 'acronym': 'MGB vs RYGB', 'briefTitle': 'Mini Gastric Bypass vs Roux enY Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Doncaster And Bassetlaw Hospitals NHS Foundation Trust'}, 'officialTitle': 'Mini Gastric Bypass vs Roux enY Gastric Bypass', 'orgStudyIdInfo': {'id': '0945 2018 NCTS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MGB', 'description': 'Mini gastric bypass', 'interventionNames': ['Procedure: Gastric bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Roux enY gastric bypass', 'description': 'Roux enY gastric bypass', 'interventionNames': ['Procedure: Gastric bypass']}], 'interventions': [{'name': 'Gastric bypass', 'type': 'PROCEDURE', 'description': 'Surgical method of gastric bypass', 'armGroupLabels': ['MGB', 'Roux enY gastric bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Final report and findings will be appropriately disseminated following completion of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Doncaster And Bassetlaw Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}