Prospective randomized, double-blind, placebo controlled trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair
Abstract
Objective: Infection is one of possible complications after prosthetic material hernia repair surgery. Antibiotic prophylaxis is applied routinely in China, but its effect is still controversial. The present study aims to offer direct clinical evidence on prevention of infection after tension-free inguinal hernia repair.
Methods: A total of 1,200 cases with primary inguinal hernia treated in 6 hospitals in Shaanxi Province were enrolled in this study. They were randomly divided into three groups (n = 400 per group): placebo control group, Cefazolin group and Levofloxacin group after tensionfree inguinal hernia repair using polypropylene mesh. Hernia type, age, gender, weight and complications were recorded. The surgical-site infection was diagnosed according to APIC, CDC criteria (http://www.apic. org). Infections were evaluated every other day in the first week, and then at 14 days, 21 days and 30 days following surgery.
Results: Two cases from the placebo group, 3 from the Cefazolin group and 3 from the Levofloxacin group failed to follow-up. Six patients (2 non-following the protocol, 2 severe depression, and 2 laparoscopic surgery) from the placebo group, 14 (8 nonreceiving trial medication, 5 laparoscopic surgery, and 1 failure to tolerance) from the Cefazolin group, and 12 (2 combination of antibiotic usage, 5 laparoscopic surgery and 5 failure to tolerance) from the Levofloxacin group were excluded. The data of the 1,160 cases were statistically analyzed in the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 400 participants or records.
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