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

Tana Pradhan1, Helen Zhang1, Amanda Kadesh2

  • 1Obstetrics and Gynecology, Westchester Medical Center, New York Medical College, Valhalla, New York, USA.

BMJ Surgery, Interventions, & Health Technologies
|April 10, 2024
PubMed
Summary

Preoperative vaginal metronidazole did not significantly reduce postoperative infections or patient issues in patients undergoing hysterectomy. Further research is needed to establish its clinical benefit for preventing surgical site infections.

Keywords:
Minimally Invasive Surgical ProceduresObstetrics and Gynecology DevicesOutcomes ResearchRobotic Surgical ProceduresWomen's Health

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Area of Science:

  • Gynecology
  • Surgical Infections
  • Pharmacology

Background:

  • Surgical site infections (SSIs) and postoperative complications are significant concerns following hysterectomy.
  • Vaginal antibiotics are sometimes used to prevent infections, but evidence for their efficacy is limited.

Purpose of the Study:

  • To evaluate the effectiveness of a 5-day course of vaginal metronidazole administered before hysterectomy in reducing postoperative infections and patient issues.
  • To assess the impact of this intervention on patient-reported outcomes and documented infections.

Main Methods:

  • A randomized controlled trial was conducted comparing vaginal metronidazole (5 days pre-surgery) to no intervention in patients scheduled for hysterectomy.
  • Sample size was calculated for 80% power to detect a 20% difference in infection/issue rates.
  • 133 patients (68 metronidazole, 65 control) were included; outcomes were assessed 4-8 weeks post-surgery.

Main Results:

  • No significant difference was observed in the composite rate of patient-reported issues and/or documented postoperative infection between the metronidazole and control groups (39.8% vs. 36.9%, p=0.50).
  • Individual analysis of patient-reported issues (38.3%) and documented infections (18.8%) also showed no significant group differences.
  • A per-protocol analysis, considering 73.5% compliance in the intervention arm, yielded similar non-significant results.

Conclusions:

  • The study found insufficient evidence to support the routine use of preoperative vaginal metronidazole for preventing surgical site infections or postoperative complications in hysterectomy patients.
  • Current evidence does not demonstrate a significant benefit of this prophylactic regimen.