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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess Whether Antibiotic Administration Should Be Recommended During Office Operative Hysteroscopy

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Abstract

We did a double-blind, randomized, placebo-controlled study to assess the incidence of infectious complications and the protective effect of antibiotic administration during operative hysteroscopic procedures in an office setting. A total of 1046 consecutively enrolled women with intrauterine lesions were randomly allocated to the reference group (523 patients administered with 1 g of cefazolin intramuscularly) and the study group (523 patients administered with 10 mL of isotonic sodium chloride solution), and treated in office setting by operative hysteroscopy for endometrial polypectomy, uterine septa, submucosal myomas, and intrauterine adhesions. The primary outcome measure was the computation of difference between groups in postsurgical infectious complications occurring in the 5 days after the procedures. The time spent in performing the various procedures did not differ significantly (P > .05) between the groups. With respect to the overall rate of postsurgical infection, we found that 12 (1.15%) of 1046 patients referred with symptoms related to infective complications, 7 (1.3% of 523 women) in the study—untreated—group and 5 (1.0% of 523 women) in the reference group. Such incidences did not differ significantly between the groups (P > .05). Antibiotics were prescribed in all cases of postsurgical infection and the infective process resolved in few days. None of these patients developed serious infections with adnexal involvement, as confirmed by clinical and ultrasounds evaluation. The results of the current study would support the American College of Obstetricians and Gynecologists recommendation not to prescribe routine antibiotic administration in the case of hysteroscopic surgery.

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Authors and Affiliations

  1. Department of Surgical Sciences, Unit of Obstetrics and Gynaecology, University of Foggia, Foggia, Italy

    Luigi Nappi MD, PhD & Pantaleo Greco MD

  2. Department of Gynaecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples “Federico II”, Naples, Italy

    Attilio Di Spiezio Sardo MD, PhD, Marialuigia Spinelli MD & Carmine Nappi MD

  3. Department of Obstetrics & Gynecology, University of Salerno, Salerno, Italy

    Maurizio Guida MD

  4. Centro Oncologico Fiorentino “CFO,” Sesto Fiorentino, Italy

    Luca Mencaglia MD

  5. UOC Obstetrics & Gynecology, “San Giuseppe” Hospital, Empoli, Italy

    Marco Filippeschi MD & Pasquale Florio PhD, MD

  6. Department of Paediatrics, Obstetrics & Reproductive Medicine, Section of Obstetrics & Gynecology, University of Siena, Siena, Policlinico “Le Scotte,”, Viale Bracci, 53100, Siena, Italy

    Pasquale Florio PhD, MD

Authors
  1. Luigi Nappi MD, PhD
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  2. Attilio Di Spiezio Sardo MD, PhD
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  3. Marialuigia Spinelli MD
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  4. Maurizio Guida MD
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  5. Luca Mencaglia MD
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  6. Pantaleo Greco MD
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  7. Carmine Nappi MD
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  8. Marco Filippeschi MD
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  9. Pasquale Florio PhD, MD
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Corresponding author

Correspondence to Pasquale Florio PhD, MD.

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Nappi, L., Di Spiezio Sardo, A., Spinelli, M. et al. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Assess Whether Antibiotic Administration Should Be Recommended During Office Operative Hysteroscopy. Reprod. Sci. 20, 755–761 (2013). https://doi.org/10.1177/1933719112466308

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