BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial
Schop SSJ., Hommes JE., Krastev TK., Derks D., Larsen M., Rakhorst H.
Randomized Controlled Trial with a reported sample of 196, published in BMJ Open (2021) — summary generated from the PubMed abstract.
Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Randomized Controlled Trial
- Journal
- BMJ Open (2021)
- Reported sample size
- 196
- Source database
- Europe PMC
- PMID
- 34531218
- PMCID
- PMC8449986
- DOI
- 10.1136/bmjopen-2021-051413
- NCT
- NCT02339779
- Citations
- 14
Abstract (original English)
Introduction Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). Methods and analysis This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. Ethics and dissemination Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. Trial status Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.
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