PURPOSE: to compare the efficacy of tinidazole and cephazolin on the febrile and infectious morbidity of post vaginal and abdominal hysterectomy antibiotic prophylaxis. METHODS: randomized clinical study, where women admitted to hospital for hysterectomy were randomly allocated in one of the following antibiotic prophylaxis groups: Group C (2 g of IV cephazolin in the anesthetic induction); Group T (2 g of tinidazole orally, 12 hours before the surgery); or Group C+T (2 g of tinidazole orally 12 hours before the surgery and 2g of IV cephazolin in the anesthetic induction). Cervicovaginal smears were collected for specific cultures and the diagnosis of bacterial vaginosis (BV) was based in Amsel and Nugent's criteria. The patients were reevaluated 7 and 30 days after the surgery for signs of febrile and/or infectious morbidity. The chi2 or the Fisher's exact test was used to assess differences among the three groups, with a significance level of 5%. The sample power (1-beta) was calculated through the SAS program. RESULTS: seven days after the hysterectomy, infectious morbidity was diagnosed in 6.6% of the women, but with no significant difference among the three groups studied (p=0.12). There was no febrile or infectious morbidity at the immediate post-surgical period or after 30 days from the surgery. BV ratio at the pre-surgical period was significantly higher among the women submitted to vaginal hysterectomy, rather than among the ones submitted to abdominal hysterectomy (27 versus 7%, p=0.02). BV ratio was also higher after 30 days, among the women submitted to vaginal hysterectomy (20 versus 8%), though without statistical significance (p=0.19). CONCLUSIONS: the use of tinidazole, isolated or associated with cephazolin has not presented higher efficacy, than the use of cephazolin, alone to prevent febrile or infectious morbidity post hysterectomy. The high ratio of BV at the immediate pre-surgery period among the women submitted to vaginal hysterectomy suggests that this infection must be better investigated and properly treated before the surgery.
RCT Entities:
PURPOSE: to compare the efficacy of tinidazole and cephazolin on the febrile and infectious morbidity of post vaginal and abdominal hysterectomy antibiotic prophylaxis. METHODS: randomized clinical study, where women admitted to hospital for hysterectomy were randomly allocated in one of the following antibiotic prophylaxis groups: Group C (2 g of IV cephazolin in the anesthetic induction); Group T (2 g of tinidazole orally, 12 hours before the surgery); or Group C+T (2 g of tinidazole orally 12 hours before the surgery and 2g of IV cephazolin in the anesthetic induction). Cervicovaginal smears were collected for specific cultures and the diagnosis of bacterial vaginosis (BV) was based in Amsel and Nugent's criteria. The patients were reevaluated 7 and 30 days after the surgery for signs of febrile and/or infectious morbidity. The chi2 or the Fisher's exact test was used to assess differences among the three groups, with a significance level of 5%. The sample power (1-beta) was calculated through the SAS program. RESULTS: seven days after the hysterectomy, infectious morbidity was diagnosed in 6.6% of the women, but with no significant difference among the three groups studied (p=0.12). There was no febrile or infectious morbidity at the immediate post-surgical period or after 30 days from the surgery. BV ratio at the pre-surgical period was significantly higher among the women submitted to vaginal hysterectomy, rather than among the ones submitted to abdominal hysterectomy (27 versus 7%, p=0.02). BV ratio was also higher after 30 days, among the women submitted to vaginal hysterectomy (20 versus 8%), though without statistical significance (p=0.19). CONCLUSIONS: the use of tinidazole, isolated or associated with cephazolin has not presented higher efficacy, than the use of cephazolin, alone to prevent febrile or infectious morbidity post hysterectomy. The high ratio of BV at the immediate pre-surgery period among the women submitted to vaginal hysterectomy suggests that this infection must be better investigated and properly treated before the surgery.