ArticleBMJ open2025
K-LARS trial: protocol for a multicentre randomised controlled trial evaluating a knowledge-enhanced digital intervention to prevent low anterior resection syndrome in Korea.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07041515 (A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection), which is not on this map. Not yet cited in PubMed.
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A Randomized, Multicenter Clinical Trial to Evaluate the Feasibility and Utility of a Postoperative Management App for Patients Undergoing Rectal Resection
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5 authors.
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Abstract
introductionLow anterior resection syndrome (LARS) is a common functional complication after sphincter-preserving surgery for rectal cancer that significantly impairs the quality of life. Current postoperative management strategies are suboptimal, and effective preventive approaches are lacking. This study aims to evaluate the impact of a mobile-based, knowledge-enhanced digital intervention for reducing the incidence of major LARS.
settingThis is a multicentre, open-label, parallel-group, randomised controlled trial to be conducted across three academic medical centres in Korea. METHODS AND ANALYSIS: A total of 300 adult patients who underwent low anterior resection or stoma reversal after rectal cancer surgery will be randomly assigned in a 1:1 ratio to the intervention group (mobile digital programme) or the control group (standard educational materials). The digital programme includes daily symptom monitoring, exercise suggestions, dietary recommendations and structured feedback from healthcare providers during clinical visits based on outcomes. The primary outcome is the incidence of major LARS (score ≥30) at 12 months postoperatively. Secondary outcomes include longitudinal changes in LARS score, quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30), EORTC QLQ-Colorectal Cancer 29 (CR29)), European Quality of Life 5 Dimensions Level Version (EQ-5D-5L), patient satisfaction and programme adherence. Statistical analyses will include stratified chi-squared tests and mixed-effects models based on the intention-to-treat principle. ETHICS AND DISSEMINATION: The trial received ethical approval from the Institutional Review Board of the National Cancer Centre, Korea. Written informed consent will be obtained from all participants. The findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT07041515.
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