Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT04613635
Status:
COMPLETED
Last Update Posted:
2024-12-17
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stratafix Vs. Vicryl OAGB / MGB Suture Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Closure of gastrojejunostomy', 'timeFrame': 'The assessment of this surgical step will be completed during the operation.', 'description': 'time needed to perform this specific surgical step, i.e. the ventral defect closure of the (otherwise stapled) gastrojejunostomy'}], 'secondaryOutcomes': [{'measure': 'anastomotic site perioperative morbidity', 'timeFrame': '6 months', 'description': 'Number of participants with hemorrhage, leakage or symptomatic strictures requiring further diagnostic or therapeutic measurements'}, {'measure': 'other anastomosis- related morbidity', 'timeFrame': '6 months', 'description': 'Number of participants with marginal ulcer or anastomotic stricture needing further diagnostic and/or interventions'}, {'measure': 'economical factors', 'timeFrame': '6 months', 'description': 'costs of treatment in case the above mentioned complications occur and require intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mini-Gastric Bypass', 'One Anastomosis Gastric Bypass', 'Gastroenteral Anastomosis', 'MGB', 'OAGB'], 'conditions': ['Morbid Obesity', 'Anastomotic Leak', 'Anastomotic Stenosis', 'Hemorrhage Postoperative']}, 'referencesModule': {'references': [{'pmid': '23011462', 'type': 'BACKGROUND', 'citation': 'Lee WJ, Ser KH, Lee YC, Tsou JJ, Chen SC, Chen JC. Laparoscopic Roux-en-Y vs. mini-gastric bypass for the treatment of morbid obesity: a 10-year experience. Obes Surg. 2012 Dec;22(12):1827-34. doi: 10.1007/s11695-012-0726-9.'}, {'pmid': '16259892', 'type': 'BACKGROUND', 'citation': 'Rutledge R, Walsh TR. Continued excellent results with the mini-gastric bypass: six-year study in 2,410 patients. Obes Surg. 2005 Oct;15(9):1304-8. doi: 10.1381/096089205774512663.'}, {'pmid': '24682767', 'type': 'BACKGROUND', 'citation': 'Kular KS, Manchanda N, Rutledge R. A 6-year experience with 1,054 mini-gastric bypasses-first study from Indian subcontinent. Obes Surg. 2014 Sep;24(9):1430-5. doi: 10.1007/s11695-014-1220-3.'}, {'pmid': '25585612', 'type': 'BACKGROUND', 'citation': 'Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.'}, {'pmid': '22411569', 'type': 'BACKGROUND', 'citation': 'Noun R, Skaff J, Riachi E, Daher R, Antoun NA, Nasr M. One thousand consecutive mini-gastric bypass: short- and long-term outcome. Obes Surg. 2012 May;22(5):697-703. doi: 10.1007/s11695-012-0618-z.'}, {'pmid': '23982648', 'type': 'BACKGROUND', 'citation': 'Musella M, Susa A, Greco F, De Luca M, Manno E, Di Stefano C, Milone M, Bonfanti R, Segato G, Antonino A, Piazza L. The laparoscopic mini-gastric bypass: the Italian experience: outcomes from 974 consecutive cases in a multicenter review. Surg Endosc. 2014 Jan;28(1):156-63. doi: 10.1007/s00464-013-3141-y. Epub 2013 Aug 28.'}, {'pmid': '28303503', 'type': 'BACKGROUND', 'citation': 'Taha O, Abdelaal M, Abozeid M, Askalany A, Alaa M. Outcomes of Omega Loop Gastric Bypass, 6-Years Experience of 1520 Cases. Obes Surg. 2017 Aug;27(8):1952-1960. doi: 10.1007/s11695-017-2623-8.'}, {'pmid': '27783366', 'type': 'BACKGROUND', 'citation': 'Carbajo MA, Luque-de-Leon E, Jimenez JM, Ortiz-de-Solorzano J, Perez-Miranda M, Castro-Alija MJ. Laparoscopic One-Anastomosis Gastric Bypass: Technique, Results, and Long-Term Follow-Up in 1200 Patients. Obes Surg. 2017 May;27(5):1153-1167. doi: 10.1007/s11695-016-2428-1.'}, {'pmid': '18193178', 'type': 'BACKGROUND', 'citation': 'Lee WJ, Wang W, Lee YC, Huang MT, Ser KH, Chen JC. Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. Obes Surg. 2008 Mar;18(3):294-9. doi: 10.1007/s11695-007-9367-9. Epub 2008 Jan 12.'}, {'pmid': '12194550', 'type': 'BACKGROUND', 'citation': 'Skroubis G, Sakellaropoulos G, Pouggouras K, Mead N, Nikiforidis G, Kalfarentzos F. Comparison of nutritional deficiencies after Roux-en-Y gastric bypass and after biliopancreatic diversion with Roux-en-Y gastric bypass. Obes Surg. 2002 Aug;12(4):551-8. doi: 10.1381/096089202762252334.'}]}, 'descriptionModule': {'briefSummary': 'To compare shorttime (6 months) results of two competitive suture materials with regard to time demanded to perform the concerned surgical step and secondary to study anastomotic site safety and complications like leakage and hemorrhage as well as development of anastomotic strictures. Evaluation of cost-effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients selected for primary Mini-Gastric bypass to treat obesity (BMI\\>30)\n* laparoscopic access feasable (intention to treat laparoscopically)\n* failed conservative treatment (accepted by health insurance companies)\n* relevant co-morbidities in cases with BMI \\<40\n* age 18 years or elder\n\nExclusion Criteria:\n\n* severe language problems\n* revisional or redo-procedures\n* operation intended as open procedure(extensive previous surgeries),\n* operation performed under corticoid-medication\n* operation performed under full-dose anticoagulants\n* operation performed by another surgeon than one of the 3 experienced MGB-surgeons of the Department'}, 'identificationModule': {'nctId': 'NCT04613635', 'briefTitle': 'Stratafix Vs. Vicryl OAGB / MGB Suture Study', 'organization': {'class': 'OTHER', 'fullName': 'St. Franziskus Hospital'}, 'officialTitle': 'Comparison of 2 Suture Materials for Closure of Ventral Defect At the Gastrojejunostomy in One-Anastomosis-Gastric Bypass / Mini-Gastric Bypass (OAGB / MGB): a Randomized Short Term Study with Monocrylic Spiral Knotless Tissue Control Device Vs. Traditional Polyglactin Multifilament Suture', 'orgStudyIdInfo': {'id': '20191020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stratafix', 'interventionNames': ['Device: Stratafix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vicryl', 'interventionNames': ['Device: Vicryl']}], 'interventions': [{'name': 'Stratafix', 'type': 'DEVICE', 'otherNames': ['monocrylic spiral knotless tissue control device'], 'description': 'Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread', 'armGroupLabels': ['Stratafix']}, {'name': 'Vicryl', 'type': 'DEVICE', 'otherNames': ['traditional polyglactin multifilament suture'], 'description': 'Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread', 'armGroupLabels': ['Vicryl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50825', 'city': 'Cologne', 'country': 'Germany', 'facility': 'St. Franziskus-Hospital', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Franziskus Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RWTH Aachen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Principal Investigator', 'investigatorFullName': 'Andreas Plamper', 'investigatorAffiliation': 'St. Franziskus Hospital'}}}}