A multicenter, double-blind, randomized, placebo-controlled study to assess
whether antibiotic administration should be recommended during office operative
hysteroscopy.
Author(s): Nappi L(1), Di Spiezio Sardo A, Spinelli M, Guida M, Mencaglia L, Greco P, Nappi
C, Filippeschi M, Florio P.
Affiliation(s): Author information:
(1)Department of Surgical Sciences, Unit of Obstetrics and Gynaecology, University
of Foggia, Foggia, Italy.
Publication date & source: 2013, Reprod Sci. , 20(7):755-61
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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