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Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.
- Source :
-
Lancet Oncology . Feb2017, Vol. 18 Issue 2, p251-258. 8p. - Publication Year :
- 2017
-
Abstract
- <bold>Background: </bold>The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR.<bold>Methods: </bold>We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446.<bold>Findings: </bold>142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups.<bold>Interpretation: </bold>Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved.<bold>Funding: </bold>Pink Ribbon, Nuts-Ohra, and LifeCell. [ABSTRACT FROM AUTHOR]
- Subjects :
- *BREAST cancer treatment
*MASTECTOMY
*ARTIFICIAL implants
*PLASTIC surgery
*RANDOMIZED controlled trials
*LONGITUDINAL method
*BREAST cancer surgery
*ADENOCARCINOMA
*BREAST cancer
*BREAST tumors
*BREAST implants
*CLINICAL trials
*COMPARATIVE studies
*DERMIS
*EXPERIMENTAL design
*MAMMAPLASTY
*RESEARCH methodology
*MEDICAL cooperation
*QUALITY of life
*REOPERATION
*RESEARCH
*SURGICAL complications
*TUMOR classification
*EVALUATION research
*TREATMENT effectiveness
*DUCTAL carcinoma
*LOBULAR carcinoma
Subjects
Details
- Language :
- English
- ISSN :
- 14702045
- Volume :
- 18
- Issue :
- 2
- Database :
- Academic Search Index
- Journal :
- Lancet Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 121069020
- Full Text :
- https://doi.org/10.1016/S1470-2045(16)30668-4