Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-11 @ 11:15 AM
Study NCT ID:
NCT02769559
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction Mammaplasty and Improved Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536821', 'term': 'Gigantomastia'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '2000-2014', 'description': 'Questionnaires about quality of life before and up to 12 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse outcomes', 'timeFrame': '2000-2014', 'description': 'Evaluation of rate and types of negative outcomes up to 12 years after elective reduction surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macromastia', 'Signs and Symptoms', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.', 'detailedDescription': 'The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '63 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females with macromastia undergoing elective reduction surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above 18 years\n* macromastia on clinical examination\n* fulfilled Breast Q Questionnaire prior to surgery and after surgery\n* signed informed consent\n\nExclusion Criteria:\n\n* failed to sign informed consent\n* failed to fill the Breast Q Questionnaire\n* patients with altered mental status and behaviour\n* patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer'}, 'identificationModule': {'nctId': 'NCT02769559', 'acronym': 'MammaRed', 'briefTitle': 'Reduction Mammaplasty and Improved Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bratislava'}, 'officialTitle': 'Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.', 'orgStudyIdInfo': {'id': 'UHB/005/2015/MB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with macromasty', 'description': 'Female adult patients with symptomatic macromasty selected for elective reduction surgery', 'interventionNames': ['Procedure: Reduction mammaplasty']}], 'interventions': [{'name': 'Reduction mammaplasty', 'type': 'PROCEDURE', 'description': 'Surgical removal of excess breast tissue', 'armGroupLabels': ['Patients with macromasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82101', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'University Hospital Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Bratislava', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comenius University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy.', 'investigatorFullName': 'Julius Hodosy', 'investigatorAffiliation': 'University Hospital Bratislava'}}}}