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Delayed hemorrhage after cold and hot snare resection of colorectal polyps: a multicenter randomized trial (interim analysis)

机译:冷热圈套切除结直肠息肉后延迟出血:多中心随机试验(临时分析)

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Background and study aims?Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). Patients and methods?We conducted a multicenter, randomized controlled trial. Participants scheduled to undergo endoscopic resection of colorectal polyps ≤?10?mm were enrolled and randomly assigned to CSP or HSP. Prophylactic clipping was performed at the endoscopists’ discretion. The primary outcome was delayed bleeding rate. Secondary outcomes included immediate bleeding rate and clipping rate. Sample size calculation showed that 451 patients were required in each arm. Results?At the end of the study period decided in advance, 308 participants were recruited and an interim analysis was performed. A total of 273 patients (mean age 62.2?±?8.8 years; 188 males) were analyzed, with 139 patients allocated to CSP and 134 to HSP. In total, 367 polyps were resected with CSP and 360 polyps with HSP. There were no significant differences in patient demographics or polyp characteristics. In per-patient-based analysis, delayed bleeding rates were 0.7?% after CSP and 0.7?% after HSP. Per-polyp analysis showed similar results (CSP: 0.3?% vs. HSP: 0.6?%). The immediate bleeding rate was significantly higher with CSP vs. HSP (54?% vs.14?%, P??0.0001), while clipping rates were 18?% and 19?%, respectively. Conclusion?This interim analysis did not demonstrate that delayed bleeding after CSP is less frequent than after HSP. The delayed bleeding rate after HSP was lower than expected.
机译:背景和研究旨在?延迟出血被认为在冷腹肌切除术(CSP)后常常发生,但这尚未在临床试验中验证。本研究旨在比较CSP和热脉络膜切除术(HSP)后延迟出血的速率。患者和方法?我们进行了多中心,随机对照试验。预定要经过结直肠息肉的内窥镜切除≤10Ωmm的参与者被纳入并随机分配给CSP或HSP。预防性剪裁以内窥镜师的自由裁量权进行。主要结果是延迟出血率。二次结果包括立即出血率和裁减率。样本量计算显示,每个臂需要451名患者。结果?在研究期结束时提前决定,招募了308名参与者,并进行了临时分析。分析了273名患者(平均年龄为62.2〜±8.8岁; 188名男性),用139名患者分配给CSP和134至HSP。总共用CSP和360息酸息肉用HSP切除367个息肉。患者人口统计或息肉特征没有显着差异。在基于患者的分析中,CSP后延迟出血率为0.7?%,HSP后0.7℃。每息肉分析显示出类似的结果(CSP:0.3?%与Hsp:0.6?%)。 CSP与HSP直接出血率明显高(54Ω·百分比,54%,p≤≤0.0001),裁减速率分别为18μm,19?%。结论?该临时分析未证明CSP后延迟出血频率低于HSP后。 HSP后的延迟出血率低于预期。

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