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对比预防性夹闭和圈套结扎在预防有蒂结直肠息肉切除术后出血的应用:一项前瞻性、随机、多中心研究。

Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study.

机构信息

Department of Internal Medicine, Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Korea.

Department of Internal Medicine, Daejeon St. Mary's Hospital, The Catholic University of Korea, Daejeon, Korea.

出版信息

Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15.

Abstract

BACKGROUND AND STUDY AIMS

The effectiveness of the prophylactic clip for the prevention of postpolypectomy bleeding in pedunculated colonic polyps has not been confirmed. The aim of this prospective, randomized study was to compare the efficacy of prophylactic clip and endoloop application in the prevention of postpolypectomy bleeding in large pedunculated polyps.

PATIENTS AND METHODS

A total of 195 patients who had pedunculated colorectal polyps, with heads ≥ 10 mm and stalks ≥ 5 mm in diameter, were included in the study between July 2010 and January 2013. Polyps were randomized to receive either clips or endoloops. Both devices were applied to the base of the stalk before conventional snare polypectomy. Bleeding complications were analyzed with a noninferiority margin of 5 %.

RESULTS

A total of 203 polyps were included in the study (98 in the clip group and 105 in the endoloop group). Bleeding occurred after five polypectomies in the clip group (5.1 %) and after six in the endoloop group (5.7 %) (P = 0.847). Noninferiority of the prophylactic clip to the endoloop could not be confirmed (absolute bleeding rate difference - 0.6 %, 95 % confidence interval - 5.6 % to 6.8 %) due to small sample size. Immediate bleeding episodes occurred in 4/5 polyps in the clip group and 5/6 polyps in the endoloop group. Delayed bleeding occurred in one polyp in each group.

CONCLUSIONS

These results suggest that the application of a prophylactic clip is as effective and safe as an endoloop in the prevention of postpolypectomy bleeding in large pedunculated colonic polyps.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov (NCT01406379).

摘要

背景与研究目的

预防性夹闭在预防有蒂结肠息肉切除术后出血方面的有效性尚未得到证实。本前瞻性、随机研究旨在比较预防性夹闭与圈套器应用在预防大的有蒂息肉切除术后出血方面的疗效。

患者与方法

2010 年 7 月至 2013 年 1 月期间,共纳入 195 例具有头径≥10mm、蒂径≥5mm 的有蒂结直肠息肉患者。息肉随机分为夹闭组或圈套器组。圈套器组或夹闭组在常规圈套器息肉切除前将器械应用于蒂根部。采用非劣效性边界 5%分析出血并发症。

结果

共纳入 203 个息肉(夹闭组 98 个,圈套器组 105 个)。夹闭组 5 个息肉(5.1%)和圈套器组 6 个息肉(5.7%)发生出血(P=0.847)。由于样本量小,不能确认预防性夹闭与圈套器相比具有非劣效性(绝对出血率差异-0.6%,95%置信区间-5.6%至 6.8%)。夹闭组 4/5 个息肉和圈套器组 5/6 个息肉立即发生出血。两组各有 1 个息肉迟发性出血。

结论

这些结果表明,预防性夹闭与圈套器应用在预防大的有蒂结肠息肉切除术后出血方面同样有效且安全。

临床试验注册

ClinicalTrials.gov(NCT01406379)。

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