title: A multicenter, double-blind, randomized, placebo-controlled study to assess whether antibiotic administration should be recommended during office operative hysteroscopy.
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.
authors.affiliation: Department of Surgical Sciences, Unit of Obstetrics and Gynaecology, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Nappi
authors.forename: Attilio
authors.initials: A
authors.lastname: Di Spiezio Sardo
authors.forename: Marialuigia
authors.initials: M
authors.lastname: Spinelli
authors.forename: Maurizio
authors.initials: M
authors.lastname: Guida
authors.forename: Luca
authors.initials: L
authors.lastname: Mencaglia
authors.forename: Pantaleo
authors.initials: P
authors.lastname: Greco
authors.forename: Carmine
authors.initials: C
authors.lastname: Nappi
authors.forename: Marco
authors.initials: M
authors.lastname: Filippeschi
authors.forename: Pasquale
authors.initials: P
authors.lastname: Florio
mesh_terms: D000328:Adult; D000556:Ambulatory Surgical Procedures / Q000379:methods / Q000592:standards*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015907:Hysteroscopy / Q000379:methods / Q000592:standards*; D017410:Practice Guidelines as Topic / Q000592:standards*; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000517:prevention & control
chemical_list: D000900:Anti-Bacterial Agents