Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-02 @ 5:01 AM
Study NCT ID:
NCT03556995
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2018-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006470', 'term': 'Hemorrhage'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9044}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-15', 'studyFirstSubmitDate': '2018-06-03', 'studyFirstSubmitQcDate': '2018-06-03', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative or postoperative bleeding complication', 'timeFrame': '30 days postoperative', 'description': 'patients underwent any type of bariatric surgery in our medical network'}], 'secondaryOutcomes': [{'measure': 'treatment of the complication', 'timeFrame': '30 days postoperative', 'description': 'Treated conservatively, re operation, endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Bariatric Surgery Candidate', 'Complication', 'Bleeding']}, 'referencesModule': {'references': [{'pmid': '23338049', 'type': 'RESULT', 'citation': 'Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.'}, {'pmid': '21893621', 'type': 'RESULT', 'citation': 'Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.'}, {'pmid': '22990271', 'type': 'RESULT', 'citation': 'Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. doi: 10.1001/2012.jama.11164.'}, {'pmid': '24189773', 'type': 'RESULT', 'citation': 'Courcoulas AP, Christian NJ, Belle SH, Berk PD, Flum DR, Garcia L, Horlick M, Kalarchian MA, King WC, Mitchell JE, Patterson EJ, Pender JR, Pomp A, Pories WJ, Thirlby RC, Yanovski SZ, Wolfe BM; Longitudinal Assessment of Bariatric Surgery (LABS) Consortium. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013 Dec 11;310(22):2416-25. doi: 10.1001/jama.2013.280928.'}, {'pmid': '16839478', 'type': 'RESULT', 'citation': 'Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg. 2006 Jul;16(7):829-35. doi: 10.1381/096089206777822359.'}, {'pmid': '29101558', 'type': 'RESULT', 'citation': 'Nielsen AW, Helm MC, Kindel T, Higgins R, Lak K, Helmen ZM, Gould JC. Perioperative bleeding and blood transfusion are major risk factors for venous thromboembolism following bariatric surgery. Surg Endosc. 2018 May;32(5):2488-2495. doi: 10.1007/s00464-017-5951-9. Epub 2017 Nov 3.'}, {'pmid': '29023333', 'type': 'RESULT', 'citation': 'Fecso AB, Samuel T, Elnahas A, Sockalingam S, Jackson T, Quereshy F, Okrainec A. Clinical Indicators of Postoperative Bleeding in Bariatric Surgery. Surg Laparosc Endosc Percutan Tech. 2018 Feb;28(1):52-55. doi: 10.1097/SLE.0000000000000480.'}, {'pmid': '29503096', 'type': 'RESULT', 'citation': 'Daigle CR, Brethauer SA, Tu C, Petrick AT, Morton JM, Schauer PR, Aminian A. Which postoperative complications matter most after bariatric surgery? Prioritizing quality improvement efforts to improve national outcomes. Surg Obes Relat Dis. 2018 May;14(5):652-657. doi: 10.1016/j.soard.2018.01.008. Epub 2018 Jan 12.'}, {'pmid': '15383786', 'type': 'RESULT', 'citation': 'Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg. 2004 Oct;240(4):586-93; discussion 593-4. doi: 10.1097/01.sla.0000140752.74893.24.'}, {'pmid': '28836135', 'type': 'RESULT', 'citation': 'Nimeri AA, Bautista J, Ibrahim M, Philip R, Al Shaban T, Maasher A, Altinoz A. Mandatory Risk Assessment Reduces Venous Thromboembolism in Bariatric Surgery Patients. Obes Surg. 2018 Feb;28(2):541-547. doi: 10.1007/s11695-017-2909-x.'}, {'pmid': '25105982', 'type': 'RESULT', 'citation': 'Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4.'}]}, 'descriptionModule': {'briefSummary': "As bleeding is a major risk in bariatric surgeries, we aimed our study to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.", 'detailedDescription': "Were collected retrospectively the data of all patients (age 18 and older) that underwent bariatric surgery in Assuta Hospitals (Assuta is a nationwide privet hospitals network), during the years 2013-2016.\n\nPatients underwent one of three procedures:\n\n* laparoscopic sleeve gastrectomy (LSG),\n* laparoscopic gastrectomy by-pass (LGBP)\n* laparoscopic adjustable gastric band (LAGB) Demographic data of patients was collected (age, gender. BMI, habits, smoking, alcohol consumption etc.), as well as medical history, background diseases, family medical history, previous surgeries and procedures, chronic treatments, use of medications etc., We have also collected surgeons and hospital data - in which hospital was the surgery done? Surgery technique, surgeon's experience, capacity of surgeon - how many bariatric surgeries are done by the surgeon per months? Statistical analyses was done using chi square and Fisher's exact test for analyzing specific single variables. When analyzing the possible connection between BMI and bleeding, BMI values were split into three categories 30\\<BMI\\<35, 35\\<BMI\\<40 and BMI\\>40. The use of single variable analyses enabled us to focus on a relatively small number of variables in the multivariable analyses. Variables that were statistically significant (p\\<0.05) were used as independent variables in logistic regression tests."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that underwent any bariatric surgery in Assuta medical network, composed by 4 hospital of High Volume of bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:all patients that underwent bariatric surgery -\n\nExclusion Criteria: Under 18 years old\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03556995', 'briefTitle': 'Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Medical Center'}, 'officialTitle': 'Score Scale to Assess Risk of Bleeding in Bariatric Surgery', 'orgStudyIdInfo': {'id': '01-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bariatric surgery patients', 'description': 'All patients above 18 that underwent bariatric surgery', 'interventionNames': ['Other: bariatric surgery patients']}], 'interventions': [{'name': 'bariatric surgery patients', 'type': 'OTHER', 'armGroupLabels': ['Bariatric surgery patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Assuta MC', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing Data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of the department of general surgery', 'investigatorFullName': 'Sergio Gabriel Susmallian', 'investigatorAffiliation': 'Assuta Medical Center'}}}}