Pathway of Low Anterior Resection Syndrome (LARS) Relief After Surgery (POLARiS) Trial Protocol. A prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort to explore the natural history of LARS and compare the trans-anal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS.

Julie Croft, Emily Farrow, Alexandra Coxon-Meggy, Katie Gordon, Neil Corrigan, Hannah Mather, Deborah Stocken, Megan Dale, Huey Yi Chong, Judith White, Laura Knight, Alun Meggy, Christina Lloydwin, Betty Tan, Ashley Douglas, Ralph Powell, Julie Hepburn, David Jayne, Jared Torkington, Andrea Warwick, Kheng-Seong Ng, Kate Wilson, Charles Knowles, Aaron Quyn, Julie Cornish
{"title":"Pathway of Low Anterior Resection Syndrome (LARS) Relief After Surgery (POLARiS) Trial Protocol. A prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort to explore the natural history of LARS and compare the trans-anal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS.","authors":"Julie Croft, Emily Farrow, Alexandra Coxon-Meggy, Katie Gordon, Neil Corrigan, Hannah Mather, Deborah Stocken, Megan Dale, Huey Yi Chong, Judith White, Laura Knight, Alun Meggy, Christina Lloydwin, Betty Tan, Ashley Douglas, Ralph Powell, Julie Hepburn, David Jayne, Jared Torkington, Andrea Warwick, Kheng-Seong Ng, Kate Wilson, Charles Knowles, Aaron Quyn, Julie Cornish","doi":"10.1101/2024.08.19.24312209","DOIUrl":null,"url":null,"abstract":"Introduction\nAs 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\nThe objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of trans-anal irrigation (TAI) or sacral neural modulation (SNM) compared to optimised conservative management (OCM) for people with major LARS. All patients who have had an anterior resection in the last 10 years who meet the eligibility criteria will be invited to participate in the cohort. Patients identified as having a major LARS score (LARS score ≥30) and who meet the eligibility criteria will be invited to take part in the randomised controlled trial (RCT). Cohort and RCT participants will be followed up for a 24-month period, and will complete a series of questionnaires measuring LARS symptoms and quality-of-life, 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 at 24 months. 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 vs OCM and SNM vs OCM. Ethics and Dissemination\nEthical 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 upon request and published on completion of the trial in a peer-reviewed journal and at international conferences Trial Registration Number ISRCTN12834598 Registered 04/08/2023\nACTRN12623001166662\nRegistered 10/11/2023","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"medRxiv - Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2024.08.19.24312209","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

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 trans-anal irrigation (TAI) or sacral neural modulation (SNM) compared to optimised conservative management (OCM) for people with major LARS. All patients who have had an anterior resection in the last 10 years who meet the eligibility criteria will be invited to participate in the cohort. Patients identified as having a major LARS score (LARS score ≥30) and who meet the eligibility criteria will be invited to take part in the randomised controlled trial (RCT). Cohort and RCT participants will be followed up for a 24-month period, and will complete a series of questionnaires measuring LARS symptoms and quality-of-life, 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 at 24 months. 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 vs OCM and SNM vs OCM. 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 upon request and published on completion of the trial in a peer-reviewed journal and at international conferences Trial Registration Number ISRCTN12834598 Registered 04/08/2023 ACTRN12623001166662 Registered 10/11/2023
低位前切除综合症(LARS)术后缓解途径(POLARiS)试验协议。这是一项前瞻性、国际性、开放标签、多臂、第 3 期随机分组优越性试验,旨在探究 LARS 的自然病史,并比较经肛门灌注和骶神经调控与针对重大 LARS 患者的优化保守治疗。
导言:随着生存率的提高,人们越来越认识到直肠癌手术的不良后果。低位前切除综合症(LARS)就是这样一种后果,它描述了直肠癌手术后的一系列肠道症状,包括便急、大便失禁、大便成团和排便不完全。LARS 对患者的生活质量(QoL)有很大的负面影响,多达 75% 的患者在术后第一年会出现 LARS 症状。尽管如此,人们对其自然病史却知之甚少,而且支持当前治疗方案的证据也不充分。方法和分析POLARiS的目的是探索LARS的自然病史,并评估经肛门灌注(TAI)或骶神经调节(SNM)与优化保守治疗(OCM)相比,对重大LARS患者的临床和成本效益。所有在过去 10 年中接受过前部切除术且符合资格标准的患者都将被邀请参加该群组。被确定为重度 LARS(LARS 评分≥30 分)且符合资格标准的患者将被邀请参加随机对照试验 (RCT)。将对队列研究和随机对照试验的参与者进行为期 24 个月的随访,并完成一系列测量 LARS 症状和生活质量的问卷调查,以及对随机对照试验参与者的临床审查。此外,还将进行过程评估、定性子研究和经济评估。POLARiS 队列和 RCT 的主要结果指标是 24 个月时的 LARS 评分。RCT 分析将在意向治疗的基础上进行。每个终点的疗效比较分析将包括两个成对治疗比较:TAI vs OCM 和 SNM vs OCM。伦理与传播英国威尔士 REC 4(参考文献:23/WA/0171)和澳大利亚悉尼地方卫生区 HREC(参考文献:2023/ETH00749)已批准了该试验。本试验的结果将应要求向参与者公布,并在试验结束后在同行评审期刊和国际会议上发表。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信