|- candidate number||22958|
|- NTR Number||NTR5446|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-okt-2015|
|- Secondary IDs||PRHC-2012-RS01-version 4 |
|- Public Title||Breast Reconstruction In One Stage|
|- Scientific Title||Skin sparing mastectomy with implant reconstruction: clinical outcomes and cost effectiveness of reconstruction in one stage with the use of a collagen matrix.
A randomized clinical trial.
|- ACRONYM||BRIOS Study|
|- hypothesis||The aim of this study is to compare clinical outcomes and cost-effectiveness of two procedures for skin sparing mastectomy with implant reconstruction in a randomized clinical trial. The currently preferred two-stage breast reconstruction with implantation of a tissue expander during a first, and placement of a breast prosthesis during a second surgery will be compared to the novel one-stage immediate breast reconstruction, where implants are combined with a collagen matrix inlay (Strattice™).|
The use of a collagen matrix in combination with definitive implants in immediate breast reconstruction after skin sparing mastectomy is a good one-stage alternative for the traditional two-stage procedure because we think it
I. has the same or a lower complication rate;
II. gives equal or a better cosmetic result;
III. is less painful to the patient;
IV. Is more cost-effective.
|- Healt Condition(s) or Problem(s) studied||Mastectomy, Breast reconstruction|
|- Inclusion criteria||Females are included if they meet the following criteria:|
▪ women with the BRCA 1/2 gen mutation who will undergo prophylactic treatment
▪ intended to undergo a skin sparing mastectomy
▪ willing and able to participate;
▪ aged 18 and over;
▪ able to provide informed consent and
▪ able to complete questionnaires.
|- Exclusion criteria||Exclusion criteria are:|
▪ women with a body mass index > 30
▪ woman who need a too large breast size according to the specialist
▪ woman who receive a polyurethaan implant
▪ women who did not quit smoking two weeks before surgery
▪ oncologic patients who have to receive post-operative radiotherapy
▪ pregnancy or planning a pregnancy during the study;
▪ ongoing severe psychiatric illness or mental retardation;
▪ evidence of alcohol and/or drug abuse;
▪ inability to complete the questionnaires;
▪ local or general infection which could jeopardize the surgical objective;
▪ extensive local inflammatory reactions;
▪ proven or suspected hypersensitivity to materials;
▪ immunosuppressive pathologies.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-jun-2016|
|- Target number of participants||140|
|- Interventions||Patients whom are eligible for the study and give informed consent will be operated by a plastic surgeon. Skin sparing mastectomy and implant reconstruction will be performed in all patients. Patients will be randomized to treatment group 1 or 2 three days before the mastectomy. In treatment group 1 a tissue expander will be placed during a first surgery, and abreast prosthesis will be placed during a second surgery. In the time between the first and second surgery the tissue expander will be filled repeatedly. |
In treatment group 2, patients will undergo a skin sparing mastectomy with immediate placement of a breast implant combined with a collagen matrix sheet (Strattice™).
|- Primary outcome||The primary endpoint of the study is the quality of life as measured by a specific breast related questionnaire (BREAST-Q) at one year after placement of the permanent prosthesis. This questionnaire was elected because it is especially suitable and valid for the post-mastectomy population. |
|- Secondary outcome||Complication rate (e.g. infection, implant loss, seroma, contraction of the breast), aesthetic outcome (as measured by a panel of experts at one year after placement of the permanent prosthesis), pain, and patient burden with regard to the number of procedures and time invested are secondary outcomes. |
|- Timepoints||The follow-up moments will be arranged as following:|
Surgery - 2 weeks post-op - 6 weeks – 3 months - 6 months – 12 months post-op.
Tissue Expander - Fillings – Implant – 2 weeks – 6 weeks – 3 months - 6 months – 12 months post-op.
|- Trial web site||www.vumc.nl/brios|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||PhD-candidate Rieky E. Dikmans|
|- CONTACT for SCIENTIFIC QUERIES||PhD-candidate Rieky E. Dikmans|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Pink Ribbon, Nuts/Ohra, LifeCell|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||8-okt-2015 - 22-nov-2015|