Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:13 PM
Study NCT ID:
NCT04812132
Status:
RECRUITING
Last Update Posted:
2021-03-23
First Post:
2021-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT Comparing OAGB and Long Limb Roux Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2036-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-21', 'studyFirstSubmitDate': '2021-02-27', 'studyFirstSubmitQcDate': '2021-03-21', 'lastUpdatePostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Excess weight loss %', 'timeFrame': '10 years', 'description': 'Calculated loss of the excess weight'}, {'measure': 'Impact on type 2 diabetes mellitus', 'timeFrame': '10 years', 'description': 'Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %'}, {'measure': 'Impact on type 2 diabetes mellitus', 'timeFrame': '10 years', 'description': 'Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)'}, {'measure': 'Impact on hypertensive disease', 'timeFrame': '10 years', 'description': 'Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)'}, {'measure': 'Impact on total cholesterol', 'timeFrame': '10 years', 'description': 'Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).'}, {'measure': 'Impact on hyperlipidemia', 'timeFrame': '10 years', 'description': 'Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)'}, {'measure': 'Impact on hyperlipidemia', 'timeFrame': '10 years', 'description': 'Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)'}, {'measure': 'Impact on hyperlipidemia', 'timeFrame': '10 years', 'description': 'Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)'}, {'measure': 'Impact on hyperlipidemias', 'timeFrame': '10 years', 'description': 'Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides'}], 'secondaryOutcomes': [{'measure': 'Nutritional deficiencies: anemia', 'timeFrame': '10 years', 'description': '% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)'}, {'measure': 'Nutritional deficiencies', 'timeFrame': '10 years', 'description': 'Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)'}, {'measure': 'GERD', 'timeFrame': '10 years', 'description': '% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OAGB', 'Long biliary limb Roux gastric bypass', 'Metabolic surgery', 'Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.\n\nWe plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.\n\nOther outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.\n\nThere are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.\n\nThere are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI over 35 and obesity related disease\n* BMI over 40\n* age between 18-60 years\n* agrees to participate in the study\n\nExclusion Criteria:\n\n* age under 18 years or over 60 years\n* abundant adhesions discovered during the surgery\n* active upper gastrointestinal ulcer disease\n* prior bariatric surgery\n* active symptomatic reflux disease\n* active psychiatric disease (eg psychosis)'}, 'identificationModule': {'nctId': 'NCT04812132', 'acronym': 'OAGBvsLLbypass', 'briefTitle': 'RCT Comparing OAGB and Long Limb Roux Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.', 'orgStudyIdInfo': {'id': 'TartuUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Women', 'interventionNames': ['Procedure: One-anastomosis gastric bypass', 'Procedure: Long biliary limb Roux gastric bypass']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Men', 'interventionNames': ['Procedure: One-anastomosis gastric bypass', 'Procedure: Long biliary limb Roux gastric bypass']}], 'interventions': [{'name': 'One-anastomosis gastric bypass', 'type': 'PROCEDURE', 'description': 'One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)', 'armGroupLabels': ['Men', 'Women']}, {'name': 'Long biliary limb Roux gastric bypass', 'type': 'PROCEDURE', 'description': 'Other group is planned to receive a long biliary limb Roux gastric bypass', 'armGroupLabels': ['Men', 'Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50406', 'city': 'Tartu', 'status': 'RECRUITING', 'country': 'Estonia', 'contacts': [{'name': 'Eva-Maria Kikkas, Dr', 'role': 'CONTACT', 'email': 'evamariakikkas@gmail.com', 'phone': '+37258162720'}, {'name': 'Toomas Sillakivi, Dr, PhD', 'role': 'CONTACT', 'email': 'toomas.sillakivi@kliinikum.ee'}], 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Estonia Medical Centre', 'class': 'OTHER'}, {'name': 'Fertilitas (private clinic)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor and Teaching staff', 'investigatorFullName': 'Eva-Maria Kikkas', 'investigatorAffiliation': 'Tartu University Hospital'}}}}