Antimicrobial Prophylaxis in Laparoscopic Gynecologic Surgery: A Prospective Randomized Study Comparing Amoxicillin-Clavulanic Acid with Cefazolin

Abstract

Numerous studies have been published in recent years about antimicrobial prophylaxis in gynecologic surgery, but the optimal drug and schedule for the different surgical procedures is still a matter of debate. The aim of the present study was to compare two ultra-short term antimicrobial prophylaxis regimens (amoxicillin-clavulanic acid and cefazolin) in preventing infections following laparoscopic gynecologic operations. Three hundred sixty women hospitalized for a laparoscopic gynecologic surgery procedure were included in the study between January 1999, and December 2001. Patients were randomly allocated to receive amoxicillin-clavulanic acid (2.2 g) [Group A] or cefazolin (2 g) [Group B] as a single dose 30 minutes before surgery. Each patient was assessed daily until discharge to evidence febrile status and the presence of infections at the operative site, urinary tract and respiratory tract. In the amoxicillin-clavulanic acid (Group A) and cefazolin (Group B) groups, overall 164 and 172 patients, respectively, were evaluable for prophylactic efficacy at hospital discharge. Infectious complications were infrequent in both groups with febrile morbidity occurring in only one patient (0.6%) in the amoxicillin-clavulanic group. No sign of infections at the surgical site, urinary tract and respiratory tract was observed in either group. No death due to sepsis was recorded. It is concluded that ultra-short term prophylaxis with both amoxicillin-clavulanic acid and cefazolin is safe and effective in elective laparoscopic gynecologic surgery.

Antibiotic prophylaxis for selected gynecologic surgeries

“…Two RCTs were identified that evaluated antibiotic use in benign gynecologic laparoscopic procedures excluding hysterectomy [22,23]. Kocak et al [22] randomized 450 women to either a single preoperative dose of a first‐generation cephalosporin (n = 200) or no antibiotics (n = 250).…”

“…Cormio et al [23] randomized 356 patients undergoing laparoscopy to amoxicillin–clavulanate or cefazolin at anesthesia induction. Surgeries included ovarian cystectomy, myomectomy, adnexectomy, and endometriosis.…”

Antibiotic Prophylaxis in Gynecologic Laparoscopy: Study Protocol for a Randomized Controlled Trial

“…Thus, for our sample size calculation, it was considered that clinically relevant a 5.5% difference in SSI rate. In this review, Morrill et al [9] found only two randomized clinical trials that evaluated antibiotic use in benign gynecologic laparoscopic procedures, excluding hysterectomy [26,27]. Kocak et al randomized 450 women to either a single preoperative dose of a first-generation cephalosporin (n=200) or no antibiotics (n=250) [26].…”

Role of prophylactic antibiotics in endoscopic gynaecological surgery; a consensus proposal

“…Based on the above data, the SOGC recommends against the use of prophylaxis for laparoscopic procedures that do not involve breach to the uterine cavity or vagina. A second RCT found no differences in infection rates between two different antibiotics (amoxicillin-clavulanic acid and cefazolin) used for prophylaxis in a variety of laparoscopic procedures that included total hysterectomy [13]. This RCT however involved no placebocontrolled group; therefore, no conclusions can be drawn regarding the actual benefit of prophylaxis.…”