Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 12:57 PM
Study NCT ID:
NCT05743166
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Surgery Observation Study Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term weight loss', 'timeFrame': '10-15 years after surgery', 'description': 'Total weight loss after bariatric surgery'}], 'secondaryOutcomes': [{'measure': 'Remission of comorbidities after bariatric surgery', 'timeFrame': '10-15 years after surgery', 'description': 'Remission of Type 2 Diabetes Mellitus, Hypertension and Sleep Apnoe'}, {'measure': 'Quality of life after bariatric surgery', 'timeFrame': '10-15 years after surgery', 'description': 'Health related quality of life, SF -36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years\n\nThe main question\\[s\\] it aims to answer are:\n\n* The duration of the surgical method on weight reduction and remission of comorbidities\n* Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to\n\n * fill inn questionnaires,\n * have a clinical examinition\n * have an interview with nurse and doctor\n * have blood samples taken\n * undergo other investigations', 'detailedDescription': 'The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.\n\n1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1400 patients who had baratric surgery at three public hospitals in Central Norway from 2010 to 2015 are invited to a follow up in 2023-2025', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015\n\nExclusion Criteria:\n\n* Not able to consent for participation\n* Includable participants not longer living in Norway'}, 'identificationModule': {'nctId': 'NCT05743166', 'acronym': 'BAROBS2', 'briefTitle': 'Bariatric Surgery Observation Study Part 2', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.', 'orgStudyIdInfo': {'id': 'StOlavsH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'otherNames': ['Roux-en-Y gastsric bypass', 'Sleeve gastrectomy'], 'description': 'JDF11 JDF41 JDF97'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6017', 'city': 'Ålesund', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jorunn Sandvik, PhD', 'role': 'CONTACT', 'email': 'jorunn.sandvik@stolav.no', 'phone': '+4997734018'}, {'name': 'Kirsti Kverndokk Bjerkan, MSc', 'role': 'CONTACT', 'email': 'kirsti.kverndokk.bjerkan@helse-mr.no', 'phone': '+4792400081'}], 'facility': 'Helse Møre og Romsdal', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'zip': '7800', 'city': 'Namsos', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Siren Nymo, PhD', 'role': 'CONTACT', 'email': 'siren.nymo@helse-nordtrondelag.no', 'phone': '+4799514188'}, {'name': 'Hallvard Græslie, MD', 'role': 'CONTACT', 'email': 'hallvard.greslie@helse-nordtrondelag.no', 'phone': '+4791376579'}], 'facility': 'Helse Nord-Trondelag', 'geoPoint': {'lat': 64.46624, 'lon': 11.49572}}, {'zip': '7030', 'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Jorunn Sandvik, PhD', 'role': 'CONTACT', 'email': 'jorunn.sandvik@stolav.no', 'phone': '+4797734018'}, {'name': 'Åsne Ask Hyldmo, MD', 'role': 'CONTACT', 'email': 'asne.ask.hyldmo@stolav.no', 'phone': '+4747378717'}], 'facility': 'St. Olavs Univeristy Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Jorunn Sandvik, PhD', 'role': 'CONTACT', 'email': 'jorunn.sandvik@stolav.no', 'phone': '+47977340'}, {'name': 'Siren Nymo, PhD', 'role': 'CONTACT', 'email': 'siren.nymo@helse-nordtrondelag.no', 'phone': '+4799514188'}], 'overallOfficials': [{'name': 'Jorunn Sandvik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}, {'name': 'Helse Møre og Romsdal HF', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}