Location of acupoints in SA group.

PurposeLow anterior resection syndrome (LARS), a frequent postoperative complication of rectal resection, has been shown to significantly impact patients’ quality of life. Electroacupuncture (EA), a non-pharmaceutical treatment, ameliorates gastrointestinal symptoms and promotes bowel movement. However, high-quality clinical evidence is lacking. This study aimed to determine whether EA can improve LARS symptoms compared with sham electroacupuncture (SA).Study design and methodsThis multicenter, randomized, sham-controlled clinical trial will be carried out across the outpatient clinics of three tertiary medical centers in China. A total of 136 patients with LARS who meet the inclusion criteria will be randomly allocated, in equal proportions (1:1), to either the EA or SA group. Each patient will undergo treatment three times weekly during the first four weeks and twice-weekly sessions over the subsequent four weeks. After the intervention, a 24-week follow-up period will be conducted. The primary outcome is the change in the LARS score from baseline to the end of week 8. Secondary outcomes include changes in the LARS score at other time points, response rate of patients showing reduced defecation dysfunction, subjective distress related to intestinal symptoms, Wexner Diarrhea score, Bristol Bowel Diary, EORTC-QLQ-C30 Quality of Life Questionnaire, and Fecal Incontinence Quality of Life Scale.DiscussionThis study will provide evidence of EA from multiple perspectives, investigate its potential application in LARS after rectal cancer surgery, and guide the development of therapy tailored to meet specific individual health needs.Ethics and disseminationEthical approval for this study was granted by the Ethics Committee of Beijing University of Chinese Medicine (No. 2024BZYLL0402). All participants enrolled in the trial will provide written informed consent prior to randomization. Results will be prepared for submission to a peer-reviewed academic journal.Trial registrationITMCTR2024000195. International Traditional Medicine Clinical Trial Registry (http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=badb9af5-248b-4818-b3b6-25002f0fa0d5).

研究背景与目的：低位前切除综合征（Low anterior resection syndrome, LARS）是直肠切除术常见的术后并发症，已被证实可显著影响患者的生活质量。电针（Electroacupuncture, EA）作为一种非药物治疗手段，能够改善胃肠道症状并促进肠道蠕动，但目前尚缺乏高质量的临床证据支持。本研究旨在探究相较于假电针（Sham electroacupuncture, SA），电针是否能够改善LARS患者的相关症状。

研究设计与方法：本研究为多中心、随机、假对照临床试验，将在中国三家三级医疗中心的门诊开展。共计136名符合纳入标准的LARS患者将以1:1的比例随机分配至电针组与假电针组。所有患者在前4周每周接受3次治疗，后续4周调整为每周2次治疗。干预结束后，将开展为期24周的随访。本研究的主要结局指标为LARS评分从基线至第8周末的变化值；次要结局指标包括：其他时间点的LARS评分变化、排便功能障碍改善的患者应答率、肠道症状相关主观痛苦程度、韦克斯纳腹泻评分（Wexner Diarrhea score）、布里斯托排便日志（Bristol Bowel Diary）、欧洲癌症研究与治疗组织生活质量问卷（EORTC-QLQ-C30），以及粪便失禁生活质量量表（Fecal Incontinence Quality of Life Scale）。

讨论：本研究将从多维度提供电针治疗的临床证据，探究其在直肠癌术后LARS患者中的应用潜力，并为制定个体化的健康治疗方案提供参考依据。

伦理与成果发布：本研究已获得北京中医药大学伦理委员会的伦理批准（批准号：2024BZYLL0402）。所有入组受试者将在随机分组前签署书面知情同意书。研究结果将投稿至同行评议学术期刊发表。

临床试验注册：本研究已在国际传统医学临床试验注册平台（International Traditional Medicine Clinical Trial Registry）完成注册，注册号为ITMCTR2024000195，注册链接为：http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=badb9af5-248b-4818-b3b6-25002f0fa0d5。