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多中心随机对照试验比较两种结肠镜检查前肠道准备失败后的肠道清洁方案。

A Multicenter Randomized Controlled Trial Comparing Two Bowel Cleansing Regimens for Colonoscopy After Failed Bowel Preparation.

机构信息

Division of Gastroenterology, Western University, London, Ontario, Canada; Lawson Health Research Institute, London Health Sciences Centre, London, Ontario, Canada.

Division of Gastroenterology, University of Montreal, Montreal, Quebec, Canada.

出版信息

Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1283-e1291. doi: 10.1016/j.cgh.2021.07.015. Epub 2021 Jul 10.

DOI:10.1016/j.cgh.2021.07.015
PMID:34256147
Abstract

BACKGROUND & AIMS: Failed bowel preparation for colonoscopy occurs commonly, but the optimal regimen for the subsequent attempt is unknown. High-volume preparations often are used but are not well studied. The objective of this study was to compare the efficacy, tolerability, and safety of 2 regimens for use after failed bowel preparation.

METHODS

A multicenter, endoscopist-blinded randomized controlled trial was conducted in patients who previously failed bowel preparation despite adequate compliance. Patients were randomized to 1 of 2 split polyethylene glycol (PEG) regimens, preceded by 15 mg bisacodyl: PEG 2 L the evening before and 2 L the day of colonoscopy (PEG 2+2L+bisacodyl), or 4 L and 2 L (PEG 4+2L+bisacodyl). All patients followed a low-fiber diet on both the third and second day before the procedure, followed by a clear fluid diet the day before and the morning of the colonoscopy. The primary outcome was adequate bowel preparation, defined as a Boston Bowel Preparation Scale total score of 6 or higher, with all segment scores of 2 or higher. Secondary outcomes included adenoma detection rate, advanced adenoma detection rate, sessile serrated lesion detection, cecal intubation rate, tolerability, and adverse events.

RESULTS

A total of 196 subjects were randomized at 4 academic centers in Canada (mean age, 60.7 y; SD, 11.4 y; 44.9% were women). There were no significant differences between the PEG 2+2L+bisacodyl and the PEG 4+2L+bisacodyl groups in achieving adequate bowel preparation (91.2% vs 87.6%; P = .44). There were no significant differences with regard to mean adenoma detection rate (37.4% vs 31.5%; P = .41), advanced adenoma detection rate (18.7% vs 11.2%; P = .16), sessile serrated lesion detection (8.8% vs 5.6%; P = .41), and cecal intubation rate (96.7% vs 92.1%; P = .19). The 2 regimens were similarly well tolerated, but PEG 2+2L+bisacodyl was associated with a higher willingness to repeat the bowel preparation (91.2% vs 66.2%; P < .001).

CONCLUSIONS

Split-dose 4 L-PEG with 15 mg bisacodyl, along with dietary restrictions, has similar efficacy as a higher-volume preparation, and should be considered for patients who previously failed bowel preparation (ClinicalTrials.gov number, NCT02976805).

摘要

背景与目的

结肠镜检查中常出现肠道准备失败,但后续尝试的最佳方案尚不清楚。大容量制剂通常被使用,但尚未得到充分研究。本研究旨在比较两种方案在肠道准备失败后的疗效、耐受性和安全性。

方法

这是一项多中心、内镜医师设盲、随机对照临床试验,纳入了既往肠道准备充分但仍失败的患者。患者被随机分为 2 组,分别接受以下 2 种聚乙二醇(PEG)方案:PEG 2 L 于前一天晚上和结肠镜检查当天服用(PEG 2+2L+bisacodyl),或 4 L 和 2 L(PEG 4+2L+bisacodyl)。所有患者在检查前第 3 天和第 2 天遵循低纤维饮食,然后在检查前 1 天和结肠镜检查当天上午遵循清淡液体饮食。主要结局为肠道准备充分,定义为波士顿肠道准备量表总分达到 6 分或以上,所有节段评分均达到 2 分或以上。次要结局包括腺瘤检出率、高级别腺瘤检出率、平坦型锯齿状病变检出率、盲肠插管率、耐受性和不良事件。

结果

在加拿大的 4 个学术中心共纳入 196 例患者(平均年龄 60.7 岁,标准差 11.4 岁;44.9%为女性)。PEG 2+2L+bisacodyl 组和 PEG 4+2L+bisacodyl 组在实现肠道准备充分方面无显著差异(91.2% vs 87.6%;P=0.44)。两组的平均腺瘤检出率(37.4% vs 31.5%;P=0.41)、高级别腺瘤检出率(18.7% vs 11.2%;P=0.16)、平坦型锯齿状病变检出率(8.8% vs 5.6%;P=0.41)和盲肠插管率(96.7% vs 92.1%;P=0.19)均无显著差异。两种方案的耐受性相似,但 PEG 2+2L+bisacodyl 组更愿意重复肠道准备(91.2% vs 66.2%;P<0.001)。

结论

PEG 2+2L+bisacodyl 与饮食限制联合使用的分剂量 4 L-PEG 方案与大容量制剂疗效相当,对于肠道准备失败的患者应考虑使用(ClinicalTrials.gov 编号:NCT02976805)。

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