UNASSIGNED: This is a randomized, controlled, non-inferiority trial conducted between November 2021 and March 2022. Patients with non-pedunculated small colorectal polyps (<10 mm) and who did not take anticoagulants were randomly allocated to two groups: (i) the normal diet (ND) group, and (ii) the low-residue diet (LRD) group. The ND group was instructed to eat anything after CSP, whereas the LRD group was advised to take LRD for 3 days after CSP. The primary endpoint was the occurrence of delayed major bleeding that needed endoscopic hemostasis.
UNASSIGNED: A total of 193 patients (average 57.5 years old, 51.9% male) were enrolled in the study. Subsequently, 97 and 96 patients were allocated to the ND and LRD group, respectively. The occurrence of delayed major bleeding was 1.0% in the ND group and 2.1% in the LRD group (95% confidence interval [CI]: -4.4% to 2.4%; difference: -1.1%), which showed the non-inferiority of the ND group. In addition, there was no difference between the two groups with respect to the occurrence of minor delayed bleeding (3.1% and 4.2%, respectively; difference: -1.1% [95% CI: -6.4% to 4.2%]).
UNASSIGNED: Dietary restriction after CSP for low-bleeding-risk colorectal polyps is not necessary for the prevention of delayed bleeding (Registration number: UMIN000045669).
■这是一个随机的,控制,2021年11月至2022年3月期间进行的非劣效性试验。将未患结直肠小息肉(<10mm)且未服用抗凝药的患者随机分为两组:(i)正常饮食(ND)组,和(ii)低残留饮食(LRD)组。ND组被指示在CSP后吃任何东西,而LRD组建议在CSP后服用LRD3天。主要终点是需要内镜止血的迟发性大出血的发生。
■共有193名患者(平均年龄57.5岁,51.9%男性)参加研究。随后,97和96例患者被分配到ND和LRD组,分别。ND组的延迟性大出血发生率为1.0%,LRD组为2.1%(95%置信区间[CI]:-4.4%至2.4%;差异:-1.1%),这表明ND组的非劣效性。此外,两组之间在轻微延迟出血的发生率方面没有差异(3.1%和4.2%,分别;差异:-1.1%[95%CI:-6.4%至4.2%])。
■低出血风险结直肠息肉CSP后的饮食限制对于预防延迟出血是不必要的(注册编号:UMIN000045669)。