Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05785351
Status:
COMPLETED
Last Update Posted:
2023-03-27
First Post:
2023-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swedish National Benchmarks in Laparoscopic Bariatric Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55372}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-24', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Benchmark values of variables related to surgical quality', 'timeFrame': 'Surgical intervention and up to one year after surgery', 'description': 'ABC method of variables related to surgical quality (duration of surgery (minutes), complications (percentage), reoperations (percentage), weight loss at one year (percentage) etc)'}, {'measure': 'Number of participants with severe postoperative complications', 'timeFrame': 'Within 30 days and one year after surgery', 'description': 'Severe complication is defined as Clavien-Dindo grade ≥ IIIa'}], 'secondaryOutcomes': [{'measure': 'Potential risk groups for complications', 'timeFrame': 'Within 30 days and one year after surgery', 'description': 'Estimated with multivariable regression analysis looking at BMI (kg/m\\^2), age categories, gender, waist line category, occurrence of dyspepsia, hypertension, previous thrombo-embolism or diabetes'}, {'measure': 'Risk-adjusted benchmark values', 'timeFrame': 'Within 30 days and one year after surgery', 'description': 'ABC method of any identified risk group(s) for complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Bariatric Surgery', 'Laparoscopy', 'Benchmarking'], 'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.', 'detailedDescription': 'The data source will be the Scandinavian Obesity Surgery Registry (SOReg), a prospective quality registry for obesity surgery. The time frame will be 2012-2021. The techniques to be investigated are laparoscopic roux-en-y gastric bypass and laparoscopic gastric sleeve respectively. Register variables related to surgical quality will be analyzed, and related to risk of peroperative and postoperative complications. The study will analyze data for the time of surgery and up to one year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with obesity undergoing elective bariatric surgery in order to achieve weight loss.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults ≥ 18 years of age\n* primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass\n\nExclusion Criteria:\n\n* other organ surgery at the time of the index operation\n* no data about surgery\n* no data about follow-up'}, 'identificationModule': {'nctId': 'NCT05785351', 'briefTitle': 'Swedish National Benchmarks in Laparoscopic Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Region Östergötland'}, 'officialTitle': 'Bariatric Surgery Benchmarks - How Much Do We Bench?', 'orgStudyIdInfo': {'id': '2022-04311-01-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic Bariatric Surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic Bariatric Surgery: Gastric Sleeve and Roux-en-Y Gastric Bypass'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Östergötland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ebba Kihlstedt Pasquier', 'investigatorAffiliation': 'Region Östergötland'}}}}