Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer
Introduction As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urge...
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2025-02-01
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| author | Deborah D Stocken Charles H Knowles Jared Torkington David Jayne Julie Hepburn Laura Knight Neil Corrigan Julie Cornish Katie Gordon Ashley Douglas Kate Wilson Megan Dale Julie Croft Christina Lloydwin Alexandra Harriet Coxon-Meggy Judith White Alun Meggy Aaron Quyn Emily Farrow Kheng-Seong Ng Hannah Mather Huey Yi Chong Betty Tan Ralph Powell Andrea Warwick |
| author_facet | Deborah D Stocken Charles H Knowles Jared Torkington David Jayne Julie Hepburn Laura Knight Neil Corrigan Julie Cornish Katie Gordon Ashley Douglas Kate Wilson Megan Dale Julie Croft Christina Lloydwin Alexandra Harriet Coxon-Meggy Judith White Alun Meggy Aaron Quyn Emily Farrow Kheng-Seong Ng Hannah Mather Huey Yi Chong Betty Tan Ralph Powell Andrea Warwick |
| author_sort | Deborah D Stocken |
| collection | DOAJ |
| description | Introduction As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.Methods and analysis The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).Ethics and dissemination Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.Trial registration number ISRCTN12834598; ACTRN12623001166662. |
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| institution | Kabale University |
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| publishDate | 2025-02-01 |
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| spelling | doaj-art-aca845630d15455289b642087b973c792025-02-04T05:25:20ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-092612Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancerDeborah D Stocken0Charles H Knowles1Jared Torkington2David Jayne3Julie Hepburn4Laura Knight5Neil Corrigan6Julie Cornish7Katie Gordon8Ashley Douglas9Kate Wilson10Megan Dale11Julie Croft12Christina Lloydwin13Alexandra Harriet Coxon-Meggy14Judith White15Alun Meggy16Aaron Quyn17Emily Farrow18Kheng-Seong Ng19Hannah Mather20Huey Yi Chong21Betty Tan22Ralph Powell23Andrea Warwick24Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKCentre for Academic Surgery, Barts and The London School of Medicine and Dentistry Blizard Institute, London, UKColorectal Surgery, University Hospital of Wales, Cardiff and Vale University Health Board, Cardiff, UKDepartment of Colorectal Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UKInvolving People Wales, Health and Care Research Wales, Cardiff, UKCEDAR, University Hospital of Wales Healthcare NHS Trust, Cardiff, UKClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKCardiff and Vale University Health Board, Cardiff, UKClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKNHMRC Clinical Trials Centre, University of Sydney CAR, Glebe, New South Wales, AustraliaCentral Clinical School, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, AustraliaCardiff and Vale University Health Board, Cardiff, UKClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKCwm Taf Morgannwg University Health Board, Abercynon, UKColorectal Surgery, University Hospital of Wales, Cardiff and Vale University Health Board, Cardiff, UKCEDAR, University Hospital of Wales Healthcare NHS Trust, Cardiff, UKResearch and Development, Cardiff and Vale University Health Board, Cardiff, UKConsultant Colorectal Surgeon, Leeds Teaching Hospitals NHS Trust Centre for Respiratory Medicine, Leeds, UKSchool of Medicine, Cardiff University, Cardiff, UKDepartment of Colorectal Surgery, Royal Prince Alfred Hospital, Camperdown, New South Wales, AustraliaClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKCardiff and Vale University Health Board, Cardiff, UKNHMRC Clinical Trials Centre, University of Sydney CAR, Glebe, New South Wales, AustraliaInvolving People Wales, Health and Care Research Wales, Cardiff, UKDepartment of Colorectal Surgery, QEII Jubilee Hospital, Acacia Ridge, Queensland, AustraliaIntroduction As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low anterior resection syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on quality of life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options.Methods and analysis The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of transanal irrigation (TAI) or sacral neuromodulation (SNM) compared with optimised conservative management (OCM) for people with major LARS.POLARiS is a prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort design, with internal pilot phase, qualitative sub-study, process evaluation and economic evaluation. Approximately 1500 adult participants from UK hospitals and 500 from Australian hospitals who have undergone a high or low anterior resection for colorectal cancer in the last 10 years will be recruited into the cohort. Six-hundred participants from the UK and 200 participants from Australia, with major LARS symptoms, defined as a LARS score of ≥30, will be recruited to the randomised controlled trial (RCT) element. Participants entering the RCT will be randomised between OCM, TAI or SNM, all with equal allocation ratios.Cohort and RCT participants will be followed up for a 24-month period, completing a series of questionnaires measuring LARS symptoms and QoL, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted.The primary outcome measure of the POLARiS cohort and RCT is the LARS score up to 24 months post-registration/randomisation. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI versus OCM and SNM versus OCM. Secondary outcomes include health-related QoL, adverse events, treatment compliance and cost-effectiveness (up to 24 months post-registration/randomisation).Ethics and dissemination Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants on request and published on completion of the trial in a peer-reviewed journal and at international conferences.Trial registration number ISRCTN12834598; ACTRN12623001166662.https://bmjopen.bmj.com/content/15/2/e092612.full |
| spellingShingle | Deborah D Stocken Charles H Knowles Jared Torkington David Jayne Julie Hepburn Laura Knight Neil Corrigan Julie Cornish Katie Gordon Ashley Douglas Kate Wilson Megan Dale Julie Croft Christina Lloydwin Alexandra Harriet Coxon-Meggy Judith White Alun Meggy Aaron Quyn Emily Farrow Kheng-Seong Ng Hannah Mather Huey Yi Chong Betty Tan Ralph Powell Andrea Warwick Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer BMJ Open |
| title | Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer |
| title_full | Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer |
| title_fullStr | Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer |
| title_full_unstemmed | Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer |
| title_short | Pathway Of Low Anterior Resection syndrome (LARS) relief after Surgery (POLARiS): protocol for an international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort, with economic evaluation, process evaluation and qualitative sub-study, to explore the natural history of LARS and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS following a high or low anterior resection for colorectal cancer |
| title_sort | pathway of low anterior resection syndrome lars relief after surgery polaris protocol for an international open label multi arm phase 3 randomised superiority trial within a cohort with economic evaluation process evaluation and qualitative sub study to explore the natural history of lars and compare transanal irrigation and sacral neuromodulation to optimised conservative management for people with major lars following a high or low anterior resection for colorectal cancer |
| url | https://bmjopen.bmj.com/content/15/2/e092612.full |
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