预防项目：一项关于术前阴道使用甲硝唑以减少子宫切除术后患者问题及感染的随机对照试验。

PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy.

作者信息

Pradhan Tana, Zhang Helen, Kadesh Amanda, Buskwofie Ama, Patankar Sonali, Menon Sharifa, Ryntz Timothy, Grimes Cara L

机构信息

Obstetrics and Gynecology, Westchester Medical Center, New York Medical College, Valhalla, New York, USA.

Obstetrics and Gynecology, Jefferson Abington Hospital, Abington, Pennsylvania, USA.

出版信息

BMJ Surg Interv Health Technol. 2024 Apr 4;6(1):e000241. doi: 10.1136/bmjsit-2023-000241. eCollection 2024.

DOI:10.1136/bmjsit-2023-000241

PMID:38596254

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11002362/

Abstract

OBJECTIVES

To evaluate if vaginal metronidazole for 5 days before hysterectomy decreases postoperative infections and patient issues.

DESIGN

This randomized trial compared vaginal metronidazole for 5 days before a scheduled hysterectomy to no intervention. Sample size calculation was based on a 20% difference in issues and infection (30% incidence and 10% in the intervention arm) with 80% power and an alpha error of 0.05 and indicated 62 subjects needed in each arm.

SETTING

Outpatient gynecology clinics at a single academic institution.

PARTICIPANTS

154 subjects were screened for eligibility between July 2020 and September 2022. 133 underwent hysterectomy including 68 subjects (51.1%) randomized to the metronidazole and 65 (48.9%) controls. Overall, the population was racially and ethnically diverse. There was no significant difference in characteristics between the two groups.

INTERVENTIONS

Vaginal metronidazole for 5 days before hysterectomy.

MAIN OUTCOME MEASURES

Postoperative patient issues and documented postoperative infections at 4-8 weeks after surgery.

RESULTS

There was no difference in the composite rate of patient-reported issues and/or documented postoperative infection (53/133 (39.8%) with no difference between groups (29/68 (42.6%) vs 24/65 (36.9%), p=0.50). There was no difference in patient-reported issues which was 51/133 (38.3%) with no difference between groups (28/68 (41.2%) vs 23/65 (33.8%), p=0.49) or in documented infections with a rate of 25/133 (18.8%) with no significant difference between groups (15/68 (22.0%) vs 10/65 (15.4%), p=0.33). In the intervention arm, the compliance rate was 73.5% for all 5 days of vaginal metronidazole, and a per-protocol analysis was performed which resulted in no significant difference between groups.

CONCLUSIONS

There is insufficient evidence to suggest a significant benefit of preoperative vaginal metronidazole to prevent surgical site infections and postoperative patient issues in patients undergoing hysterectomy.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov, NCT04478617.

摘要

目的

评估子宫切除术前5天使用阴道甲硝唑是否能降低术后感染及患者相关问题的发生率。

设计

本随机试验将计划行子宫切除术前5天使用阴道甲硝唑与不进行干预进行了比较。样本量计算基于两组在相关问题和感染方面20%的差异（干预组发生率为30%，对照组为10%），检验效能为80%，α错误为0.05，结果表明每组需要62名受试者。

地点

一所学术机构的门诊妇科诊所。

参与者

2020年7月至2022年9月期间，对154名受试者进行了资格筛查。133名受试者接受了子宫切除术，其中68名受试者（51.1%）被随机分配至甲硝唑组，65名（48.9%）为对照组。总体而言，研究人群在种族和民族上具有多样性。两组在特征上无显著差异。

干预措施

子宫切除术前5天阴道使用甲硝唑。

主要观察指标

术后4 - 8周患者的相关问题及记录在案的术后感染情况。

结果

患者报告的相关问题和/或记录在案的术后感染的综合发生率无差异（133例中有53例（39.8%），两组间无差异（68例中有29例（42.6%） vs 65例中有24例（36.9%），p = 0.50）。患者报告的相关问题无差异，133例中有51例（38.3%），两组间无差异（68例中有28例（41.2%） vs 65例中有23例（33.8%），p = 0.49）；记录在案的感染发生率为25/133（18.8%），两组间无显著差异（68例中有15例（22.0%） vs 65例中有10例（15.4%），p = 0.33）。在干预组中，阴道使用甲硝唑5天的总体依从率为73.5%，并进行了符合方案分析，结果两组间无显著差异。