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Simultanous breast reconstruction and contralateral breast symmetrisation with tissue flap


- candidate number22750
- NTR NumberNTR5408
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2015
- Secondary IDsN/A 
- Public TitleSimultanous breast reconstruction and contralateral breast symmetrisation with tissue flap
- Scientific TitleA Breast Sharing Technique for Delayed Breast Reconstruction and Contralateral Symmetrising Mammaplasty
- ACRONYM
- hypothesisOne-stage breast reconstruction with contralateral mammaplasty using a breast sharing procedure is an oncologically safe concept.
- Healt Condition(s) or Problem(s) studiedBreast reconstruction
- Inclusion criteriaPatients referred for breast reconstruction with state after mastectomy
- Exclusion criteriaPatients with small contralateral breasts
Patients with N1-3,M1
Patients with tripple-negative tumours
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-aug-2015
- planned closingdate31-aug-2015
- Target number of participants4
- InterventionsOncological follow-up will be reviewed retrospectively.
- Primary outcomeLocal recurrence of breast cancer
- Secondary outcomeNone
- TimepointsFrom 17-08-2015 to 31-08-2015 - Collection of retrospective data from case notes and photographs
- Trial web siteNone
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. Moustapha Hamdi
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Moustapha Hamdi
- Sponsor/Initiator Brussel Universitaire Ziekenhuis (UZB)
- Funding
(Source(s) of Monetary or Material Support)
Brussel Universitaire Ziekenhuis (UZB)
- PublicationsPlanned
- Brief summaryPost-mastectomy breast reconstruction is often accompanied with a contralateral reduction mammaplasty. The ‘breast sharing’ procedure uses the disposable tissue as a flap to reconstruct the post-mastectomy defect. This technique enables simultaneous breast reconstruction and contralateral symmetrisation without the morbidity of an additional flap donor site. However, controversies related to the oncological safety of this procedurę have prevented its uptake into regular clinical practice. We aim to assess the one-stage breast reconstruction with contralateral mammaplasty using a breast sharing procedure as a potenitally oncologically safe concept.
- Main changes (audit trail)
- RECORD16-aug-2015 - 28-okt-2015


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