The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2008-12

AUTHORS

Stijn van Esser, Monique GG Hobbelink, Petra HM Peeters, Erik Buskens, Iris M van der Ploeg, Willem PTHM Mali, Inne H M Borel Rinkes, Richard van Hillegersberg

ABSTRACT

BACKGROUND: With the increasing number of non palpable breast carcinomas, the need of a good and reliable localization method increases. Currently the wire guided localization (WGL) is the standard of care in most countries. Radio guided occult lesion localization (ROLL) is a new technique that may improve the oncological outcome, cost effectiveness, patient comfort and cosmetic outcome. However, the studies published hitherto are of poor quality providing less than convincing evidence to change the current standard of care. The aim of this study is to compare the ROLL technique with the standard of care (WGL) regarding the percentage of tumour free margins, cost effectiveness, patient comfort and cosmetic outcome. METHODS/DESIGN: The ROLL trial is a multi center randomized clinical trial. Over a period of 2-3 years 316 patients will be randomized between the ROLL and the WGL technique. With this number, the expected 15% difference in tumour free margins can be detected with a power of 80%. Other endpoints include cosmetic outcome, cost effectiveness, patient (dis)comfort, degree of difficulty of the procedures and the success rate of the sentinel node procedure. The rationale, study design and planned analyses are described. TRIAL REGISTRATION: (http://www.clinicaltrials.gov, study protocol number NCT00539474). More... »

PAGES

9

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1471-2482-8-9

DOI

http://dx.doi.org/10.1186/1471-2482-8-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1014050202

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/18495027


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