一种针对低位前切除综合征（LARS）患者的交互式在线信息与同伴支持应用程序（app）对生活质量的影响：一项多中心随机对照试验。

The impact of an interactive online informational and peer support application (app) for patients with low anterior resection syndrome (LARS) on quality of life: a multicenter randomized controlled trial.

作者信息

Moon Jeongyoon, Monton Olivia, Smith Allister, Demian Marie, Sabboobeh Sarah, Garfinkle Richard, Chamdroka Martha, Brown Carl, Chadi Sami, Kennedy Erin, Liberman Sender, Savard Julie, Vasilevsky Carol-Ann, Fiore Julio F, Loiselle Carmen, Zelkowitz Phyllis, Bhatnagar Sahir, Boutros Marylise

机构信息

McGill University, Montreal, Canada.

McMaster University, Hamilton, Canada.

出版信息

Surg Endosc. 2025 Feb;39(2):1308-1317. doi: 10.1007/s00464-024-11425-2. Epub 2025 Jan 8.

DOI:10.1007/s00464-024-11425-2

PMID:39779532

Abstract

INTRODUCTION

Low Anterior Resection Syndrome (LARS) describes bowel dysfunction post-restorative proctectomy (RP) and is associated with poor quality of life (QoL). The aim of this study was to assess the impact of an interactive online informational and peer support App on participants' QoL (primary outcome), LARS, and emotional distress (secondary outcomes).

METHODS

A multicentre, randomized, parallel-group trial was conducted across five Canadian colorectal surgery practices. Adult patients who: (1) underwent RP for rectal cancer and completed all treatment and (2) had major/minor LARS were included. Participants were randomized in a 1:1 ratio to treatment or comparison group, stratified by hospital site and years post-RP. The treatment group had access to the App for a period of 6 months, and the comparison group received a booklet containing the same educational material as the App. The primary outcome was change in global QoL (EORTC-QLQ-C30) from baseline to 6 months post-intervention. Per-protocol and intention to treat analysis were performed, controlling for a priori selected variables (sex, time from end of treatment).

RESULTS

Of the 101 enrolled participants, 10 individuals were lost to follow-up and 91 completed the study. Participants were well-balanced in terms of baseline characteristics, QoL and bowel dysfunction. Among the 45 App users, median log-in per person was 21, with 30 (66.7%) participants meeting criteria for adequate app usage. On intention to treat analysis, there was no statistically significant difference in QoL in the App group. On the per-protocol analysis, where only participants who met adequate App usage criteria were included in the treatment group, the group reported statistically significant improvement in QoL (β 9.5, 95% CI 4.6,14.6) and LARS (β - 2.7, 95%CI - 5.1,- 0.2) scores following App usage.

CONCLUSION

This multicenter randomized controlled trial support that, when adequately used, an interactive online informational and peer support App has the potential to improve QoL of rectal cancer survivors living with LARS post-RP.

摘要

引言

低位前切除综合征（LARS）描述了根治性直肠切除术（RP）后的肠道功能障碍，且与生活质量（QoL）较差相关。本研究的目的是评估一款交互式在线信息和同伴支持应用程序对参与者生活质量（主要结局）、LARS及情绪困扰（次要结局）的影响。

方法

在加拿大的五家结直肠外科诊所进行了一项多中心、随机、平行组试验。纳入的成年患者需满足：（1）因直肠癌接受了RP且完成了所有治疗；（2）存在严重/轻度LARS。参与者按1:1比例随机分为治疗组或对照组，按医院地点和RP术后年限分层。治疗组可使用该应用程序6个月，对照组收到一本包含与应用程序相同教育材料的手册。主要结局是从基线到干预后6个月的总体生活质量（EORTC-QLQ-C30）变化。进行了符合方案分析和意向性分析，并对预先选定的变量（性别、治疗结束后的时间）进行了控制。

结果

在101名登记参与者中，10人失访，91人完成了研究。参与者在基线特征、生活质量和肠道功能障碍方面均衡良好。在45名应用程序用户中，每人的登录中位数为21次，30名（66.7%）参与者符合应用程序充分使用标准。在意向性分析中，应用程序组的生活质量无统计学显著差异。在符合方案分析中，治疗组仅纳入符合应用程序充分使用标准的参与者，该组报告在使用应用程序后生活质量（β 9.5，95% CI 4.6,14.6）和LARS（β - 2.7，95%CI - 5.1,- 0.2）评分有统计学显著改善。