Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-01-07 @ 1:29 PM
Study NCT ID:
NCT03106233
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013524', 'term': 'Surgical Flaps'}], 'ancestors': [{'id': 'D019738', 'term': 'Surgically-Created Structures'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recipient- and donor-site complications', 'timeFrame': 'Through study completion up to an average of 12 months post-operatively', 'description': 'Recipient site: Total flap loss, partial flap loss, venous congestion, infection, hematoma, seroma, fat necrosis and wound complications. Donor site: Infection, hematoma, seroma, fat necrosis, wound complications.'}], 'secondaryOutcomes': [{'measure': 'Flap re-explorations', 'timeFrame': 'Through study completion up to an average of 12 months post-operatively', 'description': 'Total number of flaps that required a re-exploration because of arterial or venous insufficiency, hematoma or kinking of the pedicle.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast reconstruction', 'Perforator flap', 'Microsurgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.', 'genderDescription': 'Only female participants', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lateral thigh region suitable as a donor site\n* Abdomen not suitable as donor site\n* Informed consent\n\nExclusion Criteria:\n\n* Pre-operative imaging showing no suitable perforators'}, 'identificationModule': {'nctId': 'NCT03106233', 'briefTitle': 'Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps', 'orgStudyIdInfo': {'id': 'METC 14-5-095'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LTP flap breast reconstruction', 'description': 'All consecutive patients who underwent LTP flap breast reconstructions (unilateral, bilateral or stacked unilateral) between September 2012 and November 2016 at three centers in Maastricht, the Netherlands, and New York and New Orleans, the United States, were included. Autologous breast reconstruction was performed by using the upper lateral thigh region as a donor site.', 'interventionNames': ['Procedure: LTP flap']}], 'interventions': [{'name': 'LTP flap', 'type': 'PROCEDURE', 'otherNames': ['Lateral thigh perforator flap', 'Septocutaneous tensor fasciae latae (sc-TFL) flap'], 'description': 'A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.', 'armGroupLabels': ['LTP flap breast reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Stefania Tuinder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. dr.', 'investigatorFullName': 'Rene van der Hulst', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}