NYMC Faculty Publications

PROJECT PREVENT: A Randomized Controlled Trial of Preoperative Vaginal Metronidazole to Decrease Patient Issues and Infections After Hysterectomy

Author Type(s)

Faculty, Resident/Fellow

DOI

10.1136/bmjsit-2023-000241

Journal Title

BMJ Surgery Interventions and Health Technologies

Document Type

Article

Publication Date

4-4-2024

Department

Obstetrics and Gynecology

Keywords

Minimally Invasive Surgical Procedures, Obstetrics and Gynecology Devices, Outcomes Research, Robotic Surgical Procedures, Women's Health

Disciplines

Medicine and Health Sciences

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.

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