小容量分次给药在肠道清洁方面不劣于大容量分次给药，用于有结直肠切除史的患者：一项随机试验。
Split dosing with a low-volume preparation is not inferior to split dosing with a high-volume preparation for bowel cleansing in patients with a history of colorectal resection: a randomized trial.
机构信息
Division of Gastroenterology, S. Maria delle Croci Hospital, Ravenna, Italy.
Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
出版信息
Endoscopy. 2015 Oct;47(10):917-24. doi: 10.1055/s-0034-1391987. Epub 2015 Apr 24.
BACKGROUND AND STUDY AIM
The study compared the efficacy of bowel cleansing using a low-volume mixed preparation (15 mg bisacodyl plus 2 L polyethylene glycol [PEG] solution) versus a standard high-volume preparation (4 L PEG) in patients with previous colorectal resection.
PATIENTS AND METHODS
A total of 120 patients with prior colorectal resection for cancer undergoing surveillance colonoscopy were randomized to receive either a split-dose low-volume (n = 60) or high-volume (n = 60) preparation for bowel cleansing. The quality of bowel preparation, rated according to a modified Ottawa Bowel Preparation scale (mOBPS), represented the primary outcome measure. Tolerability, safety, and lesion detection rates were secondary outcomes.
RESULTS
No significant difference was observed between the low-volume and high-volume preparations in achievement of adequate cleansing (i. e. mOBPS ≤ 4; low-volume vs. high-volume group, 85.0 % vs. 81.7 %, P = 0.624). The low-volume preparation showed a higher success rate for cleansing of the right colon (P = 0.025); better tolerability in terms of intake of the whole amount of the preparation (P < 0.001) was also observed. According to the logistic regression analysis, the only predictors of unsuccessful cleansing were previous left colectomy (P = 0.012) and a longer elapsed time since the intervention (P = 0.034). Lesion detection rates were comparable between the groups. No serious adverse events were reported.
CONCLUSION
A low-volume preparation is not inferior to a high-volume preparation for adequate bowel cleansing in patients with prior colorectal resection for cancer. If larger, multicenter, prospective studies confirm our findings, a low-volume preparation will represent a more tolerable option for such patients.
TRIAL REGISTRATION NUMBER
ClinicalTrial.gov identifier NCT01887158.
背景和研究目的
本研究比较了低容量混合制剂（15mg 比沙可啶加 2L 聚乙二醇[PEG]溶液）与标准大容量制剂（4L PEG）在既往结直肠切除术后患者中进行肠道清洁的疗效。
患者和方法
共纳入 120 例因癌症行既往结直肠切除术且正在接受监测性结肠镜检查的患者，随机分为低容量（n=60）或大容量（n=60）准备组接受肠道清洁。改良渥太华肠道准备量表（mOBPS）评分的肠道准备质量为主要观察指标。耐受性、安全性和病变检出率为次要观察指标。
结果
低容量和大容量准备组在获得足够清洁程度（即 mOBPS≤4）方面无显著差异（低容量组 vs. 大容量组，85.0% vs. 81.7%，P=0.624）。低容量准备组在右半结肠清洁方面成功率更高（P=0.025），且患者对整个准备剂量的接受度更好（P<0.001）。根据逻辑回归分析，肠道清洁不成功的唯一预测因素是既往左结肠切除术（P=0.012）和干预后时间间隔较长（P=0.034）。两组病变检出率相当。未报告严重不良事件。
结论
对于既往因癌症而行结直肠切除术的患者，低容量准备与大容量准备在获得足够肠道清洁方面效果相当。如果更大规模、多中心、前瞻性研究证实我们的发现，低容量准备将成为此类患者更耐受的选择。
临床试验注册号
ClinicalTrials.gov 标识符 NCT01887158。
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