Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:06 AM
Study NCT ID:
NCT05560633
Status:
COMPLETED
Last Update Posted:
2022-09-29
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-27', 'lastUpdatePostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total flap failure rate', 'timeFrame': 'Through study completion， and average of 2.5 year', 'description': 'The rate of ms-tram and diep flap were removed from the patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'DIEP', 'ms-TRAM', 'breast reconstruction', 'learning curve', 'nipple spring mastectomy'], 'conditions': ['Breast/Surgery']}, 'referencesModule': {'references': [{'pmid': '38355459', 'type': 'DERIVED', 'citation': 'Li S, Zhang S, Zhang X, Yan J, Wang S, Tan L, Rao N, Chen K, Zhu L. The learning curve of the MS-TRAM/DIEP breast reconstruction by dual-trained breast surgeons. BMC Surg. 2024 Feb 14;24(1):53. doi: 10.1186/s12893-024-02344-z.'}]}, 'descriptionModule': {'briefSummary': '1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.\n2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.\n3. The complication rates of the flap and oncological safety were studied.', 'detailedDescription': 'Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.\n\nBuried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.\n\nComplication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The eligibility of patients for free-TRAM/DIEP was based on the judgement of surgeons, preference of patients, and guideline recommendation as a standard-of-care. For NSM, patients should receive standard-of-care physical examination, ultrasound, mammogram and/or MRI assessment of the involved breast. Patients with clinical involvement of the nipple areola complex (NAC) were excluded', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female breast cancer patients with age \\> 18 years\n* Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)\n\nExclusion Criteria:\n\n* Breast conserving patient\n* Implant-based breast reconstruction'}, 'identificationModule': {'nctId': 'NCT05560633', 'briefTitle': 'Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'The Feasibility of Nipple-sparing Mastectomy in Combined With Abdominal Free Flap Breast Reconstruction Without Skin Paddles for Flap Monitoring: a Single-center Experience', 'orgStudyIdInfo': {'id': 'SYSEC-KY-KS-2021-144'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}