Elvira Quintanilla, José Luis Castro, Luis Ramón Rábago, Inmaculada Chico, Ana Olivares, Alejandro Ortega, Cristina Vicente, Jorge Carbó, Francisco Gea
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引用次数: 41
Abstract
Background: The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.
Objective: To study whether the use of hemoclips reduces PPB complications.
Materials and methods: Prospective, randomised study of patients with pedunculated polyps larger than 10 mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-). This study has been registered with the trial registration number NCT01565993.
Results: 105 polypectomies were performed (98 patients), 66 (62.9%) in the HC group. The total rate of complications was 10,6% in the HC group (4.5% early bleeding, 1.5% severe delayed bleeding, 4,5% mucosal burns, 1.5% perforation). In the SP group, the rate of total complications was 7,7%, (7,7% early bleeding, no significant differences). In view of the unexpected increase in the morbidity of the hemoclip group, the study was suspended without reaching the sample size. In an ad hoc analysis, which includes the standard polypectomy patients who refused to participate in the study (35 polyps), the total morbidity was 5,7% (no perforations and 2 patients with premature bleeding).When we compared the morbidity of the HC group to the morbidity of SP group plus R group (74 polyps), we also failed to detect any significant differences in terms of PPB, but did in terms of perforation.
Conclusion: The prophylactic use of hemoclips in polypectomies of large pedunculated polyps leads to a further risk of mucosal burns and perforation that is not acceptable, and does not reduce the risk of PPB.
背景:预防息肉切除术后出血(PPB)的方法尚未标准化,有小组使用血夹。目的:探讨血夹是否能减少PPB并发症的发生。材料和方法:对大于10mm的带蒂息肉患者进行前瞻性随机研究。患者分为两组(息肉切除术前血夹- hc -和标准息肉切除术- sp -)。本研究已注册,试验注册号为NCT01565993。结果:共行息肉切除术105例(98例),HC组66例(62.9%)。HC组总并发症发生率为10.6%(早期出血4.5%,严重迟发性出血1.5%,粘膜烧伤4.5%,穿孔1.5%)。SP组总并发症发生率为7.7%(早期出血7.7%,差异无统计学意义)。鉴于血夹组发病率的意外增加,在未达到样本量的情况下暂停研究。在一项特别分析中,包括拒绝参加研究的标准息肉切除术患者(35例息肉),总发病率为5.7%(无穿孔和2例早出血)。当我们将HC组的发病率与SP组加R组(74个息肉)的发病率进行比较时,我们也没有发现PPB方面有任何显著差异,但穿孔方面有显著差异。结论:在大带蒂息肉切除术中预防性使用血夹会导致粘膜烧伤和穿孔的进一步风险,这是不可接受的,并且不能降低PPB的风险。