Colorectal cancer is the third most common cancer worldwide with 5,000 patients in Australia being diagnosed with rectal cancer per year. Over half of those patients will undergo major resectional surgery. Low Anterior Resection Syndrome (LARS) is a consequence of this surgery and describes a constellation of bowel symptoms including urgency, faecal incontinence, stool clustering and incomplete evacuation.
The purpose of this study is to determine: a) if sacral nerve modulation and/or transanal irrigation will reduce the severity of LARS symptoms in patients who underwent anterior resection surgery when compared to an optimised conservative treatment, and b) understand more about how LARS changes over time. This study hopes to find out how well different treatments work for LARS, and whether one treatment might be better than the others.
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Summary |
There are two parts to the POLARiS Study – the cohort and the randomised control trial (RCT). In the cohort, all participants will complete surveys every three months over a two-year period regarding their quality of life and bowel symptoms. These surveys will take around 30 minutes to complete the full set of questionnaires at each timepoint. For participants who have major symptoms, they can move to the RCT where they will be randomly placed (by chance) into one of 3 treatment groups: 1. Sacral nerve stimulation, involving a minor surgical procedure under anaesthetic to insert a wire close to the sacral nerve, which is in the lower part of the back above the buttocks. 2. Self-administered bowel flushes, called transanal irrigation, completed at home every 1-2 days for 24 months after being trained by nursing/physiotherapy staff. 3. Optimised Conservative Management with a clinician. Participants in the RCT will complete questionnaires designed to capture health-related quality of life at baseline and 3 monthly throughout the 2-year follow-up period. |
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Supported by |
NIHR-NHMRC Collaborative Grant |
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Eligibility |
Adult patients who have had a bowel resection surgery for bowel cancer in the last 10 years. |
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Registration ID |
ANZCTRN12623001166662 |
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Participation (countries) |
Australia, UK |
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Australian lead group |
NHMRC Clinical Trials Centre, University of Sydney, Australia |
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Status |
Recruiting now |
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Activation date |
06/12/2024 |
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Chair |
Dr Kheng-Seong Ng & Dr Andrea Warwick |
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Contact |
polaris.study@sydney.edu.au or +61 2 9562 5000 |
Planned trial sites in Australia:
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State |
Site |
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NSW |
Concord Repatriation General Hospital |
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Royal Prince Alfred Hospital |
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Chris O’Brien Lifehouse |
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Bankstown-Lidcombe Hospital |
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Liverpool Hospital |
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Campbelltown Hospital |
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QLD |
Queen Elizabeth II Jubilee Hospital |
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Princess Alexandra Hospital |
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Royal Brisbane and Women’s Hospital |
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Redcliffe Hospital |
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Surgical, Treatments and Rehabilitation Services |
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SA |
Royal Adelaide Hospital |
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Lyell McEwin Hospital |
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VIC |
University Hospital Geelong |
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St Vincent’s Hospital Melbourne |
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Peter MacCallum Cancer Centre |
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The Austin Hospital |
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WA |
Royal Perth Hospital |