背景：内窥镜检查后结直肠腺瘤(CRAs)的复发会使患者面临患结直肠癌的风险。在中医领域，结直肠疾病患者通常表现为脾虚证，并接受四君子汤治疗。因此，本试验旨在探讨四君子汤在预防和治疗CRAs复发方面的疗效和安全性。 方法：设计了一项多中心、随机、双盲、安慰剂对照试验，研究四君子汤预防和治疗CRAs切除后复发的作用。将接受CRAs切除手术的患者招募并随机分配到四君子汤组和安慰剂组，比例为1:1。干预期为12个月。随访期为24个月。主要结果是干预后的CRAs复发率。次要结果包括术后第二年的CRAs复发率、腺瘤的病理类型和干预后脾虚证症状评分的改变。 讨论：先前的临床实践观察到四君子汤对胃肠疾病的良好疗效。许多实验也验证了四君子汤的活性成分。本试验旨在为四君子汤的使用提供切实证据，希望能减少CRAs的复发。 版权所有 ©2023 Ni, Liu, Liu, Lu, Zhou, Dai, Zhao, Xu and Ji.

Background: The recurrence of colorectal adenomas (CRAs) after endoscopy predisposes patients to a risk of colorectal cancer. Guided by the traditional Chinese medicine (TCM), patients with colorectal diseases usually manifest with spleen deficiency syndrome (SDS) and are treated with Sijunzi decoction (SJZD). Therefore, this trial aims to explore the efficacy and safety of SJZD in the prevention and treatment of CRAs recurrence. Methods: SJZD on prevention and treatment of CRAs recurrence after resection: a multicenter, randomized, double-blind, placebo-controlled trial was designed. Patients who undergo polypectomy of CRAs will be recruited and randomized into a SJZD group and a placebo group in a 1:1 ratio. The intervention phase will be 12 months. The follow-up period will last 24 months. The primary outcome is the CRA recurrence rate after intervention. The secondary outcomes include the CRA recurrence rate at the second year post-polypectomy, the pathological type of adenoma and the alterations in SDS scores after intervention. Discussion: Previous clinical practice has observed the sound effect of SJZD in the context of gastrointestinal diseases. A number of experiments have also validated the active components in SJZD. This trial aims to provide tangible evidence for the usage of SJZD, hoping to reduce the recurrence of CRAs.Copyright © 2023 Ni, Liu, Liu, Lu, Zhou, Dai, Zhao, Xu and Ji.