痔切除术后填塞敷料与不敷敷料的比较：多中心、随机临床试验。

Tamponade dressing versus no dressing after haemorrhoidectomy: multicentre, randomized clinical trial.

机构信息

Ev. Krankenhaus Lippstadt, Department of Surgery II, University of Witten/Herdecke, Lippstadt, Germany.

Helios St. Elisabeth Klinik Oberhausen, Department of Surgery II, University of Witten/Herdecke, Oberhausen, Germany.

出版信息

BJS Open. 2022 May 2;6(3). doi: 10.1093/bjsopen/zrac070.

DOI:10.1093/bjsopen/zrac070

PMID:35639947

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9154318/

Abstract

BACKGROUND

Symptomatic haemorrhoids are a common anorectal disorder. The aim of the study was to investigate whether the omission of tamponade dressings after haemorrhoidectomy reduces postoperative pain without increasing the risk of severe bleeding.

METHOD

This was an open-label, randomized clinical trial conducted at 14 German hospitals. All patients with third- or fourth-degree haemorrhoids undergoing haemorrhoidectomy were considered eligible for selection in the intervention (no dressing) or control group (tamponade applied). Two co-primary outcomes were analysed by testing hierarchically ordered hypotheses. First, maximum pain intensity within 48 h after surgery was compared between the groups (superiority). This was followed by an analysis of severe bleeding complications, defined as any bleeding requiring surgical re-intervention within 7 days (non-inferiority). Secondary outcomes included health-related quality of life, patient satisfaction, haemoglobin levels, and adverse events.

RESULTS

Out of 950 patients screened, 754 were randomized and 725 received intervention (366 patients in the intervention and 359 patients in the control group). In the group with tamponade dressings, median pain intensity on the 0 to 10 scale was 6 (interquartile range (i.q.r.) 4-7). Patients without tamponade dressings reported significantly less pain (median 5 (i.q.r. 3-7), P < 0.001). In each group, five patients (1.4 per cent) experienced severe bleeding. The absolute difference for the severe bleeding rate was -0.03 per cent with the 90 per cent confidence interval ranging from -1.47 per cent to +1.41 per cent, in line with the non-inferiority aim. No significant between-group difference was found for secondary outcomes.

CONCLUSIONS

The practice of inserting tamponade dressings after haemorrhoidectomy correlates with increased postoperative pain and does not provide benefits in terms of reduced postoperative bleeding.

REGISTRATION NUMBER

DRKS00011590.

摘要

背景

症状性痔疮是一种常见的肛肠疾病。本研究旨在探讨痔切除术后不使用填塞敷料是否会降低术后疼痛而不增加严重出血的风险。

方法

这是一项在德国 14 家医院进行的开放性、随机临床试验。所有接受第三或第四度痔切除术的痔患者均被认为有资格入选干预组（不使用敷料）或对照组（使用填塞）。通过分层有序假设检验分析了两个主要结局。首先，比较两组患者术后 48 小时内的最大疼痛强度（优效性）。其次，分析严重出血并发症，定义为 7 天内需要手术再次干预的任何出血（非劣效性）。次要结局包括健康相关生活质量、患者满意度、血红蛋白水平和不良事件。

结果

在筛选的 950 名患者中，754 名患者被随机分组，725 名患者接受了干预措施（干预组 366 名患者，对照组 359 名患者）。在使用填塞敷料的组中，0 到 10 分疼痛量表的中位数疼痛强度为 6（四分位距 4-7）。未使用填塞敷料的患者报告的疼痛明显减轻（中位数 5（四分位距 3-7），P<0.001）。在每个组中，有 5 名患者（1.4%）发生严重出血。严重出血率的绝对差值为-0.03%，90%置信区间为-1.47%至+1.41%，符合非劣效性目标。次要结局在两组之间无显著差异。