Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT03765827
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the epidemiology nurse will not know the treatgment assigned.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '32342266', 'type': 'DERIVED', 'citation': 'Ruiz-Tovar J, Garcia A, Ferrigni C, Duran M. Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants. Obes Surg. 2020 Aug;30(8):2988-2993. doi: 10.1007/s11695-020-04635-9.'}]}, 'descriptionModule': {'briefSummary': 'Patients will be randomized into 2 groups:\n\n* Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses\n* Control group: Vitamin E will not be applied\n\nPostoperative pain will be assessed 24 hours after surgery.', 'detailedDescription': 'Patients will be randomized into 2 groups:\n\n* Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.\n* Control group: Vitamin E will not be applied\n\nPostoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>40 Kg/m2 or \\>35 Kg/m2 associated to obesity-related comorbidities\n* Patients undergoing Roux-en-Y gastric bypass as bariatric procedure\n* Patients accepting to participate in the study and signing and Informed Consent form\n\nExclusion Criteria:\n\n* Patients undergoing other bariatric techniques\n* Patients undergoing Roux-en-Y gastric bypass as revisional procedure'}, 'identificationModule': {'nctId': 'NCT03765827', 'briefTitle': 'Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain', 'orgStudyIdInfo': {'id': 'HRJC 18-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin E acetate', 'description': 'Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass', 'interventionNames': ['Drug: Vitamine E Acetate']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'No ointment will be applied', 'interventionNames': ['Drug: No application of vitamin E acetate']}], 'interventions': [{'name': 'Vitamine E Acetate', 'type': 'DRUG', 'otherNames': ['Vitamin E acetate ointment'], 'description': 'Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass', 'armGroupLabels': ['Vitamin E acetate']}, {'name': 'No application of vitamin E acetate', 'type': 'DRUG', 'otherNames': ['No application of vitamin E acetate oinment'], 'description': 'Vitamin E acetate ointment will not be applied in this group', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'country': 'Spain', 'facility': 'General Hospital Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'overallOfficials': [{'name': 'Damian Garcia, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Surgery', 'investigatorFullName': 'Jaime Ruiz-Tovar, MD, PhD', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}