PREVENT 项目:术前阴道用甲硝唑减少患者问题和子宫切除术后感染的随机对照试验

IF 2.1 Q2 SURGERY
Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes
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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][1]. Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author, TP, upon reasonable request. 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引用次数: 0

摘要

目的 评估子宫切除术前 5 天阴道使用甲硝唑是否能减少术后感染和患者问题。设计 本随机试验比较了在子宫切除术前 5 天阴道使用甲硝唑和不使用甲硝唑的情况。样本量的计算基于20%的问题和感染差异(干预组的发生率为30%,感染率为10%)、80%的功率和0.05的α误差,表明每组需要62名受试者。地点 一家学术机构的妇科门诊。参与者 2020 年 7 月至 2022 年 9 月期间,筛选出 154 名符合条件的受试者。133 人接受了子宫切除术,其中 68 人(51.1%)随机接受甲硝唑治疗,65 人(48.9%)接受对照治疗。总体而言,受试者具有种族和民族多样性。两组受试者的特征无明显差异。干预措施 子宫切除术前阴道注射甲硝唑 5 天。主要结果测量术后患者的问题和术后4-8周有记录的术后感染。结果 患者报告的问题和/或记录在案的术后感染综合率(53/133(39.8%),组间无差异(29/68(42.6%) vs 24/65(36.9%),P=0.50)。患者报告的问题为 51/133(38.3%),组间无差异(28/68(41.2%)vs 23/65(33.8%),P=0.49),有记录的感染率为 25/133(18.8%),组间无显著差异(15/68(22.0%)vs 10/65(15.4%),P=0.33)。在干预组中,5 天阴道使用甲硝唑的依从率为 73.5%,按协议分析结果显示组间无显著差异。结论 没有足够的证据表明术前阴道使用甲硝唑对预防子宫切除术患者的手术部位感染和术后患者问题有明显的益处。试验注册号为 ClinicalTrials.gov,[NCT04478617][1]。如有合理要求,可提供相关数据。支持本研究结果的数据可向通讯作者 TP 索取。[1]:/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04478617&atom=%2Fbmjsit%2F6%2F1%2Fe000241.atom
本文章由计算机程序翻译,如有差异,请以英文原文为准。
PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy
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][1]. Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author, TP, upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04478617&atom=%2Fbmjsit%2F6%2F1%2Fe000241.atom
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来源期刊
CiteScore
2.80
自引率
0.00%
发文量
22
审稿时长
17 weeks
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