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Individualized intervention based on a preparation-related prediction model improves adequacy of bowel preparation: A prospective, multi-center, randomized, controlled study

医学 结肠镜检查 随机对照试验 内科学 不利影响 临床终点 意向治疗分析 肠道准备 前瞻性队列研究 外科 结直肠癌 癌症
作者
Long Chen,Xiaoyu Kang,Gui Ren,Hui Luo,Linhui Zhang,Limei Wang,Jianghai Zhao,Rongchun Zhang,Xiaoying Zhang,Lina Zhao,Yanglin Pan
出处
期刊:Digestive and Liver Disease [Elsevier]
卷期号:56 (3): 436-443 被引量:2
标识
DOI:10.1016/j.dld.2023.09.001
摘要

Aims An easy-to-use preparation-related model (PRM) predicting inadequate bowel preparation (BP) was developed and proved superior to traditional models in our previous study. Here we aimed to investigate whether PRM-based individualized intervention can improve BP adequacy. Methods Patients undergoing morning colonoscopy were prospectively enrolled in 5 endoscopic centers in China. After standard BP of split-dose polyethylene glycol (PEG) was completed, patients were randomized (1:1) to the individualized group or standard group. High-risk patients predicted by PRM score ≥3 were instructed to drink an additional 1.5 L PEG in the individualized group while not in standard group. The primary endpoint was the rate of adequate BP, defined by segmental Boston bowel preparation scale ≥2. Secondary outcomes included adenoma detection rate (ADR) and adverse events. Results 900 patients were randomly allocated to the individualized group (n = 449) and the control (n = 451). Baseline characteristics were similar between the two groups. The rates of high-risk patients were 19.6 % in individualized group and 19.7 % in standard group. In intention-to-treat analysis, adequate BP was 91.8 % in individualized group and 84.7 % in the standard group (p = 0.001). Among high-risk patients, adequate BP rate was 94.3 % in individualized group and 49.3 % in standard group (p < 0.001), and ADR were 40.9 % vs 16.9 %, respectively (p < 0.001). No significant differences were found regarding the adverse events and willingness to repeat BP (all p >0.05). Conclusions The individualized intervention using an additional dose of PEG to high-risk patients predicted by PRM, significantly improved BP quality. The intervention significantly improved ADR in high-risk patients. (ClinicalTrials.gov number: NCT04434625)
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