Sun Linxi, Wei Xuqiang, Feng Tienan, Gu Qunhao, Li Jing, Wang Ke, Zhou Jia
Acupuncture Anesthesia Clinical Research Institute, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, 227# South Chongqing Road, Xuhui, Shanghai, 200025, China.
Int J Colorectal Dis. 2024 Dec 9;39(1):198. doi: 10.1007/s00384-024-04768-8.
INTRODUCTION: The incidence of postoperative gastrointestinal dysfunction (POGD) is notably high among patients following colorectal cancer surgery, highlighting the urgency for the prompt development of efficacious preventive and therapeutic approaches. Electroacupuncture (EA) represents an intervention modality that holds promise for the management of POGD. However, the existing empirical evidence substantiating its efficacy remains scarce. The aim of this study is to evaluate the efficacy and safety of EA as a treatment for POGD in patients undergoing colorectal cancer surgery. METHODS: This study is a multicenter, parallel-group, randomized controlled trial, named as CORRECT. CORRECT trial will recruit 300 participants diagnosed with colorectal cancer and about to undergo radical surgery across four sub-centers. The participants will be randomly assigned to one of three groups: the EA group, sham-electroacupuncture group, or control group, with a randomization ratio of 2:2:1. All groups will follow a standardized Enhanced Recovery After Surgery (ERAS) protocol. The EA group will receive EA at acupoints LI4, SJ6, ST36, and ST37, while the SA group will undergo sham-electroacupuncture. The treatments will be administered twice daily from the day of surgery until the fourth day after the operation. The primary endpoint is the time to first flatus, while secondary endpoints encompass time to first defecation, bowel sound emergence, initial water intake, duration of postoperative hospitalization, nausea and vomiting, pain levels, and blinded evaluations. Additional outcomes include medication usage and complication rates, et al. DISCUSSION: The CORRECT trial aims to provide high-quality evidence for the role of EA in the treatment of POGD following colorectal cancer surgery. It will contribute data towards the integration of acupuncture into ERAS protocols. Insights from the trial could help in tailoring treatment plans based on individual patient responses to EA, optimizing care on a case-by-case basis. TRIAL REGISTRATION: Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on November 2023 with the ClinicalTrials.gov Identifier: NCT06128785. URL: https://clinicaltrials.gov/study/NCT06128785?tab=history&a=1#study-details-card .
引言：结直肠癌手术后患者的术后胃肠功能障碍（POGD）发生率显著较高，这凸显了迅速开发有效预防和治疗方法的紧迫性。电针（EA）是一种有望用于管理POGD的干预方式。然而，证实其疗效的现有实证证据仍然匮乏。本研究的目的是评估电针作为结直肠癌手术患者POGD治疗方法的疗效和安全性。 方法：本研究是一项多中心、平行组、随机对照试验，名为CORRECT。CORRECT试验将在四个分中心招募300名被诊断为结直肠癌且即将接受根治性手术的参与者。参与者将被随机分配到三组之一：电针组、假电针组或对照组，随机化比例为2:2:1。所有组都将遵循标准化的术后加速康复（ERAS）方案。电针组将在合谷（LI4）、外关（SJ6）、足三里（ST36）和上巨虚（ST37）穴位接受电针治疗，而假电针组将接受假电针治疗。治疗将从手术当天开始，每天进行两次，直至术后第四天。主要终点是首次排气时间，次要终点包括首次排便时间、肠鸣音出现时间、首次进水时间、术后住院时间、恶心和呕吐、疼痛程度以及盲法评估。其他结果包括药物使用情况和并发症发生率等。 讨论：CORRECT试验旨在为电针在结直肠癌手术后POGD治疗中的作用提供高质量证据。它将为将针灸纳入ERAS方案贡献数据。该试验的见解有助于根据个体患者对电针的反应制定治疗计划，逐案优化护理。 试验注册：临床试验注册于2023年11月获得ClinicalTrials.gov委员会批准，ClinicalTrials.gov标识符：NCT06128785。网址：https://clinicaltrials.gov/study/NCT06128785?tab=history&a=1#study-details-card 。
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