Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT03240367
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2017-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Stapler Line Bleeding Control Techniquessurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-item drainage control', 'timeFrame': '8 months', 'description': 'Bleeding quantities to be noted'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.', 'detailedDescription': 'The question of the availability of cautery in RYGB surgeons'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obese patients\n\nExclusion Criteria:\n\n* Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)'}, 'identificationModule': {'nctId': 'NCT03240367', 'briefTitle': 'Comparison of Stapler Line Bleeding Control Techniquessurgery', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass', 'orgStudyIdInfo': {'id': '2016/180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'coutery', 'description': 'Stapler bloom will be stopped with cautery', 'interventionNames': ['Other: Coutery']}, {'type': 'NO_INTERVENTION', 'label': 'clips', 'description': 'Stapler bloom will be stopped with clipping'}], 'interventions': [{'name': 'Coutery', 'type': 'OTHER', 'description': 'Stapler line bleeding control with coutery', 'armGroupLabels': ['coutery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44915', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Ersin Gündoğan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'study principal investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ersin Gündoğan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'operator doctor', 'investigatorFullName': 'Ersin Gündoğan', 'investigatorAffiliation': 'Inonu University'}}}}