Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 9:11 PM
Study NCT ID:
NCT01862159
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erik.stenberg@regionorebrolan.se', 'phone': '+46196021000', 'title': 'Dr Erik Stenberg', 'organization': 'Region Örebro län, Sweden AND Örebro University, Sweden'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery', 'otherNumAtRisk': 25038, 'deathsNumAtRisk': 25038, 'otherNumAffected': 2180, 'seriousNumAtRisk': 18737, 'deathsNumAffected': 11, 'seriousNumAffected': 630}], 'otherEvents': [{'term': 'Any postoperative complication', 'notes': 'Any deviation from a normal postoperative course (that is Clavien-Dindo grade 1 or more)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25038, 'numEvents': 2180, 'numAffected': 2180}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious adverse event', 'notes': 'Any postoperative complication resulting in intervention under general anesthesia, organ failure or mortality (that is Clavien-Dindo 3b or more)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18737, 'numEvents': 630, 'numAffected': 630}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serious Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18737', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '630', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients operated after Jan 1, 2010'}, {'type': 'SECONDARY', 'title': 'Operating Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'spread': '38.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'operation', 'description': 'length of the operation', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Length of stay after the primary operation', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specific Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25038', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '2180', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Operated Patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012\n\nlaparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25038'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25038'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25038', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Operated Patients', 'description': 'All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '10.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19017', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6021', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '25038', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25038}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-30', 'studyFirstSubmitDate': '2013-05-02', 'resultsFirstSubmitDate': '2017-04-30', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-30', 'studyFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Complications', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)'}], 'secondaryOutcomes': [{'measure': 'Operating Time', 'timeFrame': 'operation', 'description': 'length of the operation'}, {'measure': 'Length of Stay', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Length of stay after the primary operation'}, {'measure': 'Specific Postoperative Complications', 'timeFrame': '30 days or the postoperative hospital stay if longer than 30 days', 'description': 'Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'postoperative complications'], 'conditions': ['Postoperative Complications']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucr.uu.se/soreg/', 'label': 'The Scandinavian Obesity Surgery Registry'}]}, 'descriptionModule': {'briefSummary': 'The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.', 'detailedDescription': 'Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.\n\nFrom the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.\n\nThe data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing bariatric surgery in Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUndergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry\n\nExclusion Criteria:\n\nUndergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.\n\nLost to follow up.'}, 'identificationModule': {'nctId': 'NCT01862159', 'briefTitle': 'Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'EPN 2012/039'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operated patients', 'description': 'Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012', 'interventionNames': ['Procedure: laparoscopic gastric bypass surgery']}], 'interventions': [{'name': 'laparoscopic gastric bypass surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic gastric bypass surgery', 'armGroupLabels': ['Operated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'University Hospital Örebro', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Ingmar Näslund, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Scandinavian Obesity Surgery Registry'}, {'name': 'Erik Stenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Örebro County'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'collaborators': [{'name': 'Scandinavian Obesity Surgery Registry', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Erik Stenberg, MD', 'investigatorAffiliation': 'Region Örebro County'}}}}