A Survey of Clinical Trials of Antibiotic Prophylaxis in Colon Surgery: Evidence against Further Use of No-Treatment Controls

Abstract

To evaluate the use of antibiotics given prophylactically of colon surgery, we examined 26 trials published from 1965 to 1980 in which patients given various antibiotic regiments were compared with controls given no antibiotic treatment. In 22 (85 per cent of these trials) antibiotics reduced postoperative wound infection (p less than 0.05 in 14). Combining the results of the trials published from 1965 to 1975 reveals a 95 per cent confidence interval from the true difference in infection rates of 14 +/- 6 per cent (36 per cent for control group vs. 22 per cent for treatment group) and the true difference in death rates of 6.7 +/- 4.4 per cent (11.2 per cent for control group vs 4.5 per cent for treatment group). Yet trials employing control groups given no treatment continue to be reported. Since the use of such controls is justified only when no effective alternative therapy exists, we believe that any further trials of antibiotic prophylaxis in colon surgery should employ a previously proved standard. However, steadily increasing efficacy of treatment means that comparisons of new therapies with standard therapies will become prohibitively expensive because of the large number of patients required.

Perfil epidemiológico e análise microbiológica da infecção de sítio cirúrgico em pacientes humanos e animais de companhia

“…Por isso, nestes tipos de cirurgia os benefícios não se sobrepõem aos riscos, de modo que não se recomenda sua utilização (Baum et al 1981, Platt et al 1990, exceto em casos especiais, como cirurgias com duração maior que 90 minutos, utilização de próteses e neurocirurgias, pacientes acima de 70 anos, desnutridos e imunodeprimidos (Dellinger 2003).…”

Perioperative antibiotic prophylaxis in laparoscopic right hemicolectomy for colon cancer: A 48-Hour regimen

“…Guidelines for the prevention of postoperative infection and proper antibiotic use have therefore been proposed by the Centers for Disease Control and Prevention (CDC) and other organizations (8,15). In digestive tract surgery, the benefits of prophylactic antibiotic administration for prevention of SSI have been established (16)(17)(18). Based on the US guidelines, single-dose administration of an antibiotic within 1 hour before surgery and the duration of administration within 24 hours after the end of surgery had been recommended, even in clean-contaminated surgery (8,15).…”

Antibiotic Prophylaxis in Colorectal Surgery: Evolving Trends

“…effective strategy for preventing SSIs following breast, appendix and colorectal surgery [8,9]. One meta-analysis of clinical trials of SAP in colon procedures demonstrated that antibiotic use significantly reduced mortality rates and SSI rates [10]. Despite evidence of effectiveness of antibiotics to prevent SSIs, previous studies have demonstrated inappropriate timing, selection, and excess duration of administration of SAP [11].…”