Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes
{"title":"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","authors":"Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes","doi":"10.1136/bmjsit-2023-000241","DOIUrl":null,"url":null,"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][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","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"81 1","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"PROJECT PREVENT: a randomized controlled trial of preoperative vaginal metronidazole to decrease patient issues and infections after hysterectomy\",\"authors\":\"Tana Pradhan, Helen Zhang, Amanda Kadesh, Ama Buskwofie, Sonali Patankar, Sharifa Menon, Timothy Ryntz, Cara L. Grimes\",\"doi\":\"10.1136/bmjsit-2023-000241\",\"DOIUrl\":null,\"url\":null,\"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][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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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