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clavulanate prophylaxis in gynecologic surgery
International Journal of Gynecology and Obstetrics 85 (2004) 59–61
Brief communication
Amoxycillinyclavulanate prophylaxis in gynecologic surgery O. Triolo*, A. Mancuso, F. Pantano Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina, Messina, Italy Received 10 May 2003; received in revised form 15 July 2003; accepted 15 July 2003 Keywords: Antibiotic prophylaxis; Gynecologic surgery; Amoxycillinyclavulanate
The association of amoxycillinyclavulanate (Augmentin䉸 GlaxoSmithKline, Verona, Italy) is used as antibiotic prophylaxis in abdominal and gynecologic surgery being effective against most bacteria, including anaerobes w1,2x. Different reported protocols of antibiotic prophylaxis tend to reduce doses and it is now usual to give a single administration before the start of the surgery w3x. To evaluate this concept, we compared the efficacy of a single preoperative dose of amoxycillinyclavulanate (AyC) with a two-dose administration, one 30 min before the operation and the other 8 h later. The study included 358 women admitted to our Department for surgery. Exclusion criteria were: allergy to the study drug, serious renal andyor hepatic diseases, antibiotic or corticosteroid treatment in the 14 days before surgery. Subjects were assigned randomly to one of the two treatment groups: 190 patients received 2.2 g of AyC i.v. before surgery (group 1), while 168 patients received a second dose after 8 h (group 2). Standard preoperative and postoperative assessment was carried out in all patients. All operations were performed by the same gynecologists. The subjects were divided according to: type of surgery, *Corresponding author. Fax: q39-090-695201.
days of postoperative hospital stay, and outcome. Febrile morbidity was defined as temperature )37.8 8C for almost 2 days; postoperative course was defined pathological if complicated by major infections occurring within the seventh day. Statistical analysis was performed using the x2-test, Fisher’s exact test and Student’s t-test. A P-value -0.05 was considered as significant. The groups were homogeneous concerning the type of surgical procedure performed (Table 1). With regard to postoperative outcome, none of the variables considered showed significant differences between the groups (Table 2). The mean days of postoperative hospital stay were 7.4 and 7.2, respectively (P)0.05). Five patients (5.2%) in the first group and four (4.8%) in the second were febrile (P)0.05): all cases resolved by reestablishing antibiotic therapy. In the first group, two cases of pathological outcome occurred (2.1%), both related to wound infection. In the second group, there were two cases (2.4%) of morbidity: a wound infection and a pelvic abscess. A further aim was to evaluate possible differences between abdominal and vaginal hysterectomy, concerning postoperative outcome. Higher mean WBC values in sub-group 1 (one dose) than in sub-group 2 (two doses) (14 533ymm3 vs. 11 291ymm3) were found in abdominal surgery
0020-7292/04/$30.00 䊚 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S0020-7292(03)00323-0
O. Triolo et al. / International Journal of Gynecology and Obstetrics 85 (2004) 59–61
60 Table 1 Surgical procedures Procedure
Abdominal Hysterectomy"BSO Myomectomy Adnexectomy andyor asportation of adnexal mass Explorative laparotomy Vaginal (Hysterectomy"BSO)
P
Group 1 (ns190)
Group 2 (ns168)
n
%
n
%
144 108 14 20
76 56.9 7.3 10.7
132 94 10 26
78.6 56 5.9 15.5
NS NS NS NS
2
1.1
2
1.2
NS
36
21.4
NS
46
24
NS, not significant.
(P)0.05). Lower postoperative mean WBC values were observed in both sub-groups of patients after vaginal surgery. The other variables did not vary significantly between the two groups (Table 3).
Most of the infections after abdominal and vaginal hysterectomy are caused by several aerobic and anaerobic bacteria migrating from the vagina and cervix: Escherichia coli and Staphylococcus aureus are the most frequently involved. In the antibacterial prophylaxis it is important to use a wide spectrum antibiotic resistant to -lactamase, such as amoxycillinyclavulanate. Statistical analysis of our data shows no difference between the two models of antibiotic prophylaxis. This is consistent with other reports, which compared AyC with other antibiotics generally used in surgical prophylaxis w2x. This antibiotic is effective regardless of the surgical method, the type of disease and the operation performed. A single dose before surgery reduces the patients’ discomfort, the incidence of drug side-effects and the selection of resistant bacterial strains. With reference to the lower mean WBC values after vaginal hysterectomy, studies comparing the para-
Table 2 Postoperative outcome Variable
Day of postsurgical stay (mean) Febrile outcome (no. of cases) Pathological outcome (no. of cases) Postoperative Hb (gyl) Postoperative WBC (nymm3)
Group 1 (ns190)
Group 2 (ns168)
P
Mean
(Range)
Mean
(Range)
7.4
(5–33)
7.2
(3–13)
NS
10
5.2%
8
4.8%
NS
4
2.1%
4
2.4%
–
11.8 10 956
(6.4–15) (4500–24 520)
11.5 10 931
(6.2–15.7) (5000–29 200)
NS NS
NS, not significant. Table 3 Postoperative outcome related to surgical method Variable
Day of hospital postsurgical stay (mean) Febrile outcome (no. of cases) Pathological outcome (no. of cases) Postoperative WBC (nymm3) NS, not significant.
Abdominal (ns276)
P
Group 1 (144)
Group 2 (132)
7.5 (5–33)
7.3 (3–13)
8 (5.5%)
Vaginal (ns82)
P
Group 1 (46)
Group 2 (36)
NS
7 (5–8)
7 (5–10)
NS
6 (4.5%)
NS
2 (4.3%)
2 (5.5%)
NS
4 (2.8%)
4 (3.0%)
NS
–
–
–
14 533
11 291
NS
10 047
9407
NS
O. Triolo et al. / International Journal of Gynecology and Obstetrics 85 (2004) 59–61
meters of surgical trauma related to tissue damage and inflammatory reaction showed higher levels in abdominal than in vaginal hysterectomy w4x. Our experience emphasizes that a single preoperative dose of AyC is safe, effective, and advisable in virtue of the lower treatment costs. References w1x Mittendorf R, Aronson MP, Berry RA, Williams MA, Kupelnick B, Klickstein A, et al. Avoiding serious infections associated with abdominal hysterectomy: a
61
meta-analysis of antibiotic prophylaxis. Am J Obstet Gynecol 1993;169:1119 –1124. w2x van der Linden MC, van Erp EJ, Ruijs GJ, Holm JP. A prospective randomized study comparing amoxycilliny clavulanate with cefuroxime plus metronidazole for perioperative prophylaxis in gynaecological surgery. Eur J Obstet Gynecol Reprod Biol 1993;50:141 –145. w3x Guaschino S, De Santo D, De Seta F. New perspectives in antibiotic prophylaxis for obstetric and gynaecological surgery. J Hosp Infect 2002;50(Suppl. A):513 –516. w4x Malik E, Buchweitz O, Muller-Steinhardt ¨ M, Kressin A, ¨ Meyhofer-Malik A, Diedrich K. Prospective evaluation of the systemic immune response following abdominal, vaginal, and laparoscopically assisted vaginal hysterectomy. Surg Endosc 2001;15:463 –466.
Brief communication
Amoxycillinyclavulanate prophylaxis in gynecologic surgery O. Triolo*, A. Mancuso, F. Pantano Department of Gynecological, Obstetric Sciences and Reproductive Medicine, University of Messina, Messina, Italy Received 10 May 2003; received in revised form 15 July 2003; accepted 15 July 2003 Keywords: Antibiotic prophylaxis; Gynecologic surgery; Amoxycillinyclavulanate
The association of amoxycillinyclavulanate (Augmentin䉸 GlaxoSmithKline, Verona, Italy) is used as antibiotic prophylaxis in abdominal and gynecologic surgery being effective against most bacteria, including anaerobes w1,2x. Different reported protocols of antibiotic prophylaxis tend to reduce doses and it is now usual to give a single administration before the start of the surgery w3x. To evaluate this concept, we compared the efficacy of a single preoperative dose of amoxycillinyclavulanate (AyC) with a two-dose administration, one 30 min before the operation and the other 8 h later. The study included 358 women admitted to our Department for surgery. Exclusion criteria were: allergy to the study drug, serious renal andyor hepatic diseases, antibiotic or corticosteroid treatment in the 14 days before surgery. Subjects were assigned randomly to one of the two treatment groups: 190 patients received 2.2 g of AyC i.v. before surgery (group 1), while 168 patients received a second dose after 8 h (group 2). Standard preoperative and postoperative assessment was carried out in all patients. All operations were performed by the same gynecologists. The subjects were divided according to: type of surgery, *Corresponding author. Fax: q39-090-695201.
days of postoperative hospital stay, and outcome. Febrile morbidity was defined as temperature )37.8 8C for almost 2 days; postoperative course was defined pathological if complicated by major infections occurring within the seventh day. Statistical analysis was performed using the x2-test, Fisher’s exact test and Student’s t-test. A P-value -0.05 was considered as significant. The groups were homogeneous concerning the type of surgical procedure performed (Table 1). With regard to postoperative outcome, none of the variables considered showed significant differences between the groups (Table 2). The mean days of postoperative hospital stay were 7.4 and 7.2, respectively (P)0.05). Five patients (5.2%) in the first group and four (4.8%) in the second were febrile (P)0.05): all cases resolved by reestablishing antibiotic therapy. In the first group, two cases of pathological outcome occurred (2.1%), both related to wound infection. In the second group, there were two cases (2.4%) of morbidity: a wound infection and a pelvic abscess. A further aim was to evaluate possible differences between abdominal and vaginal hysterectomy, concerning postoperative outcome. Higher mean WBC values in sub-group 1 (one dose) than in sub-group 2 (two doses) (14 533ymm3 vs. 11 291ymm3) were found in abdominal surgery
0020-7292/04/$30.00 䊚 2003 International Federation of Gynecology and Obstetrics. Published by Elsevier Science Ireland Ltd. All rights reserved. doi:10.1016/S0020-7292(03)00323-0
O. Triolo et al. / International Journal of Gynecology and Obstetrics 85 (2004) 59–61
60 Table 1 Surgical procedures Procedure
Abdominal Hysterectomy"BSO Myomectomy Adnexectomy andyor asportation of adnexal mass Explorative laparotomy Vaginal (Hysterectomy"BSO)
P
Group 1 (ns190)
Group 2 (ns168)
n
%
n
%
144 108 14 20
76 56.9 7.3 10.7
132 94 10 26
78.6 56 5.9 15.5
NS NS NS NS
2
1.1
2
1.2
NS
36
21.4
NS
46
24
NS, not significant.
(P)0.05). Lower postoperative mean WBC values were observed in both sub-groups of patients after vaginal surgery. The other variables did not vary significantly between the two groups (Table 3).
Most of the infections after abdominal and vaginal hysterectomy are caused by several aerobic and anaerobic bacteria migrating from the vagina and cervix: Escherichia coli and Staphylococcus aureus are the most frequently involved. In the antibacterial prophylaxis it is important to use a wide spectrum antibiotic resistant to -lactamase, such as amoxycillinyclavulanate. Statistical analysis of our data shows no difference between the two models of antibiotic prophylaxis. This is consistent with other reports, which compared AyC with other antibiotics generally used in surgical prophylaxis w2x. This antibiotic is effective regardless of the surgical method, the type of disease and the operation performed. A single dose before surgery reduces the patients’ discomfort, the incidence of drug side-effects and the selection of resistant bacterial strains. With reference to the lower mean WBC values after vaginal hysterectomy, studies comparing the para-
Table 2 Postoperative outcome Variable
Day of postsurgical stay (mean) Febrile outcome (no. of cases) Pathological outcome (no. of cases) Postoperative Hb (gyl) Postoperative WBC (nymm3)
Group 1 (ns190)
Group 2 (ns168)
P
Mean
(Range)
Mean
(Range)
7.4
(5–33)
7.2
(3–13)
NS
10
5.2%
8
4.8%
NS
4
2.1%
4
2.4%
–
11.8 10 956
(6.4–15) (4500–24 520)
11.5 10 931
(6.2–15.7) (5000–29 200)
NS NS
NS, not significant. Table 3 Postoperative outcome related to surgical method Variable
Day of hospital postsurgical stay (mean) Febrile outcome (no. of cases) Pathological outcome (no. of cases) Postoperative WBC (nymm3) NS, not significant.
Abdominal (ns276)
P
Group 1 (144)
Group 2 (132)
7.5 (5–33)
7.3 (3–13)
8 (5.5%)
Vaginal (ns82)
P
Group 1 (46)
Group 2 (36)
NS
7 (5–8)
7 (5–10)
NS
6 (4.5%)
NS
2 (4.3%)
2 (5.5%)
NS
4 (2.8%)
4 (3.0%)
NS
–
–
–
14 533
11 291
NS
10 047
9407
NS
O. Triolo et al. / International Journal of Gynecology and Obstetrics 85 (2004) 59–61
meters of surgical trauma related to tissue damage and inflammatory reaction showed higher levels in abdominal than in vaginal hysterectomy w4x. Our experience emphasizes that a single preoperative dose of AyC is safe, effective, and advisable in virtue of the lower treatment costs. References w1x Mittendorf R, Aronson MP, Berry RA, Williams MA, Kupelnick B, Klickstein A, et al. Avoiding serious infections associated with abdominal hysterectomy: a
61
meta-analysis of antibiotic prophylaxis. Am J Obstet Gynecol 1993;169:1119 –1124. w2x van der Linden MC, van Erp EJ, Ruijs GJ, Holm JP. A prospective randomized study comparing amoxycilliny clavulanate with cefuroxime plus metronidazole for perioperative prophylaxis in gynaecological surgery. Eur J Obstet Gynecol Reprod Biol 1993;50:141 –145. w3x Guaschino S, De Santo D, De Seta F. New perspectives in antibiotic prophylaxis for obstetric and gynaecological surgery. J Hosp Infect 2002;50(Suppl. A):513 –516. w4x Malik E, Buchweitz O, Muller-Steinhardt ¨ M, Kressin A, ¨ Meyhofer-Malik A, Diedrich K. Prospective evaluation of the systemic immune response following abdominal, vaginal, and laparoscopically assisted vaginal hysterectomy. Surg Endosc 2001;15:463 –466.