Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:53 AM
Study NCT ID:
NCT07347093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reversal of Roux-en-Y Gastric Bypass: A Swedish National Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-11-01', 'size': 82644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-16T03:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2026-01-07', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgical technique', 'timeFrame': 'Perioperative/periprocedural', 'description': '* Surgical approach (laparoscopic or open procedure)\n* Handling of the Roux limb (resection or reconnection)\n* Jejuno-jejunostomy technique (stapled/handsewn)\n* Pyloroplasty/pyloromyotomy (yes/no)\n* Gastro-gastrostomy technique (stapled/handsewn)\n* Blood loss during surgery (ml)\n* Operation time (minutes) -all data presented as number (frequencies)'}], 'primaryOutcomes': [{'measure': 'Symptom relief', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Symptom relief is classified as no, partial, or complete improvement.\n\nComplete improvement was defined as full resolution of the index symptom (e.g., cessation of hypoglycemia, pain-free status without analgesics).\n\nPartial improvement denoted a clinically meaningful reduction in symptom severity or frequency that did not meet criteria for complete resolution.\n\nNo improvement indicated persistent symptoms.'}], 'secondaryOutcomes': [{'measure': 'Indications for surgery', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Indications are categorized as abdominal pain, malnutrition, gastrointestinal symptoms, post-bariatric hypoglycemia, and psychological distress, and reported as number (frequencies).'}, {'measure': 'Weight outcome after surgery', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Weigth \\[in kilograms\\] will be reported at baseline (before surgery), at one year follow-up, and two-year follow-up.'}, {'measure': 'Complications', 'timeFrame': 'At 30-day follow-up and one-year follow-up after surgery.', 'description': 'Complications after surgery are registered as any complication and major complication (defined as Clavien-Dindo classification \\>=3b), presented as number (frequencies).'}, {'measure': 'Height', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Height (in meters) will be used to report BMI (in kg/m2).'}, {'measure': 'BMI', 'timeFrame': 'Through study completion, an average of 2 years.', 'description': 'Weight (in kilograms) and height (in meters) will be combined to report BMI (in kg/m2) at baseline (before surgery), at one year follow-up, andat two-year follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Roux-en-Y gastric bypass', 'Anatomical reversal', 'Indications', 'Complications', 'Outcomes'], 'conditions': ['Gastric Bypass Surgery', 'Revisional Bariatric Surgery', 'Complications After Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'Objective:\n\nTo investigates incidence, indications, symptom relief, complications, and weight outcomes after Roux-en-Y gastric bypass (RYGB) reversal.\n\nBackground:\n\nRYGB is an effective treatment for obesity, but in rare cases may be associated with severe long-term complications requiring RYGB reversal. Evidence on incidence and outcomes is limited.\n\nMethods:\n\nThis nationwide, multi-center, retrospective cohort study included all patients undergoing RYGB reversal in Sweden between 2007 and 2023. Data were obtained from the Scandinavian Obesity Surgery Registry (SOReg) and medical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National registry-based cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18years) who underwent reversal of RYGB between 2007 and 2023.\n\nExclusion Criteria:\n\n* Emergency reversal due to bowel ischemia\n* Reversal following other bariatric procedures (e.g. gastric banding)\n* Partial/functional reversals (e.g., gastro-gastric fistula or anastomosis between the Roux-limb and gastric remnant, without full reversal of RYGB)'}, 'identificationModule': {'nctId': 'NCT07347093', 'briefTitle': 'Reversal of Roux-en-Y Gastric Bypass: A Swedish National Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Vrinnevi Hospital'}, 'officialTitle': 'Reversal of Roux-en-Y Gastric Bypass: A Swedish National Cohort Study', 'orgStudyIdInfo': {'id': 'Dnr 2022-01827-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults (≥ 18years) who underwent reversal of RYGB', 'description': 'Included patients were adults (≥ 18years) who underwent reversal of RYGB between 2007 and 2023. Exclusion criteria included emergency reversal due to bowel ischemia, reversal following other bariatric procedures (e.g. gastric banding), or partial/functional reversals (e.g., gastro-gastric fistula or anastomosis between the Roux-limb and gastric remnant, without full reversal of RYGB)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60182', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}], 'overallOfficials': [{'name': 'Ellen A Andersson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Vrinnevi Hospital, Norrköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Since reversal of RYGB is a rare procedure the risk of identifying individual patients is considerable even if data are pseudonymized.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrinnevi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, senior consultant', 'investigatorFullName': 'Ellen Andersson', 'investigatorAffiliation': 'Vrinnevi Hospital'}}}}