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A randomised trial of robotic and open prostatectomy in men with localised prostate cancer

Gardiner, Robert A., Yaxley, John, Coughlin, Geoff, Dunglison, Nigel, Occhipinti, Stefano, Younie, Sandra, Carter, Rob, Williams, Scott, Medcraft, Robyn J., Bennett, Nigel, Lavin, Martin F. and Chambers, Suzanne Kathleen 2012, A randomised trial of robotic and open prostatectomy in men with localised prostate cancer, BMC cancer, vol. 12, no. 189, pp. 1-6.

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Title A randomised trial of robotic and open prostatectomy in men with localised prostate cancer
Author(s) Gardiner, Robert A.
Yaxley, John
Coughlin, Geoff
Dunglison, Nigel
Occhipinti, Stefano
Younie, Sandra
Carter, Rob
Williams, Scott
Medcraft, Robyn J.
Bennett, Nigel
Lavin, Martin F.
Chambers, Suzanne Kathleen
Journal name BMC cancer
Volume number 12
Issue number 189
Start page 1
End page 6
Total pages 6
Publisher BioMed Central
Place of publication London, England
Publication date 2012-05-25
ISSN 1471-2407
Keyword(s) prostace cancer
surgery
robotic prostatectomy
Summary Background
Prostate cancer is the most common male cancer in the Western world however there is ongoing debate about the optimal treatment strategy for localised disease. While surgery remains the most commonly received treatment for localised disease in Australia more recently a robotic approach has emerged as an alternative to open and laparoscopic surgery. However, high level data is not yet available to support this as a superior approach or to guide treatment decision making between the alternatives. This paper presents the design of a randomised trial of Robotic and Open Prostatectomy for men newly diagnosed with localised prostate cancer that seeks to answer this question.

Methods
200 men per treatment arm (400 men in total) are being recruited after diagnosis and before treatment through a major public hospital outpatient clinic and randomised to 1) Robotic Prostatectomy or 2) Open Prostatectomy. All robotic prostatectomies are being performed by one surgeon and all open prostatectomies are being performed by one other surgeon. Outcomes are being measured pre-operatively and at 6 weeks and 3, 6, 12 and 24 months post-surgery. Oncological outcomes are being related to positive surgical margins, biochemical recurrence +/ the need for further treatment. Non-oncological outcome measures include: pain, physical and mental functioning, fatigue, summary (preference-based utility scores) and domain-specific QoL (urinary incontinence, bowel function and erectile function), cancer specific distress, psychological distress, decision-related distress and time to return to usual activities. Cost modelling of each approach, as well as full economic appraisal, is also being undertaken.

Discussion
The study will provide recommendations about the relative benefits of Robotic and Open Prostatectomy to support informed patient decision making about treatment for localised prostate cancer; and to assist in treatment services planning for this patient group. Trial Registration ACTRN12611000661976
Notes This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Language eng
Field of Research 140208 Health Economics
Socio Economic Objective 920504 Men's Health
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, Gardiner et al.
Persistent URL http://hdl.handle.net/10536/DRO/DU:30047353

Document type: Journal Article
Collections: Population Health
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.