Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 6:37 PM
Study NCT ID:
NCT03003169
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2016-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mastectomy in Ambulatory Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 419}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2016-12-21', 'studyFirstSubmitQcDate': '2016-12-21', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of the type of hospitalization (ambulatory / conventional) according to the type of surgery (total / partial mastectomy) on quality of life 15 days after Intervention.', 'timeFrame': '15 days', 'description': 'Quality of life is assessed by the EORTC QLQ-C30 questionnaire BR23'}], 'secondaryOutcomes': [{'measure': 'Impact of type of hospitalization (ambulatory / conventional) depending on the type of surgery (total / partial mastectomy) on anxiety / depression of the patient 15 days after surgery.', 'timeFrame': '15 days', 'description': 'Anxiety / depressions are assessed by the Hospital Anxiety and Depression scale'}, {'measure': 'Patient satisfaction by type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)', 'timeFrame': '15 days', 'description': 'Patient satisfaction is assessed by a satisfaction care questionnaire (PATSAT 32).'}, {'measure': 'Complication rate within 15 days the intervention according to the type of hospitalization (ambulatory / conventional) for each type of surgery (total / partial mastectomy)', 'timeFrame': '15 jours', 'description': 'Postoperative complications will be classified according to Dindo- Clavien'}, {'measure': 'Estimate the conversion rate from ambulatory surgical to conventional surgery', 'timeFrame': '15 jours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgery', 'breast cancer', 'quality of life'], 'conditions': ['Mastectomy']}, 'referencesModule': {'references': [{'pmid': '32407900', 'type': 'BACKGROUND', 'citation': 'Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population includes all the patients managed for total or partial mastectomy at the institute.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient managed for breast cancer surgery\n* age \\>18 years old\n* understand and comply with the requirements of the study\n* patient must be affiliated to a social security system\n\nExclusion Criteria:\n\n* patient managed for a concomitant reconstructive surgery\n* bilateral breast surgery\n* patient already included in another clinical trial with an experimental molecule\n* men\n* patient deprived of liberty or under supervision\n* neoadjuvant therapy'}, 'identificationModule': {'nctId': 'NCT03003169', 'acronym': 'MASTAMBU', 'briefTitle': 'Mastectomy in Ambulatory Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Mastectomy in Ambulatory Breast Surgery', 'orgStudyIdInfo': {'id': 'ICL OBS 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ambulatory surgery description', 'interventionNames': ['Other: Medical questionnaire']}], 'interventions': [{'name': 'Medical questionnaire', 'type': 'OTHER', 'description': '* quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)\n* Hospital Anxiety and Depression scale\n* satisfaction care questionnaire (IN-PATSAT32)', 'armGroupLabels': ['ambulatory surgery description']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54519', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancérologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'MARCHAL FREDERIC, MD, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}