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BMC Surgery
Published in: BMC Surgery 1/2008

Open Access 01-12-2008 | Study protocol

The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study

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

Published in: BMC Surgery | Issue 1/2008

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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)
Appendix
Available only for authorised users
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Metadata
Title
The efficacy of 'Radio guided Occult Lesion Localization' (ROLL) versus 'Wire-guided Localization' (WGL) in breast conserving surgery for non-palpable breast cancer: A randomized clinical trial – ROLL study
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
Publication date
01-12-2008
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2008
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-8-9

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