29 research outputs found
Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: The PROPHY Study
Background: Use of prophylactic antibiotics after stented hypospadias repair is very common, but most research has not identified any clinical benefits of this practice. Only one study has found that postoperative prophylaxis reduces symptomatic urinary tract infections (UTIs). Data from the same trial suggested that prophylaxis may also reduce urethroplasty complications. No studies on this subject have been placebo-controlled.
Objective: We performed a randomized, double-blind, placebo-controlled study to evaluate the effect of postoperative prophylactic antibiotics on the incidence of infection or urethroplasty complications after stented repair of midshaft-to-distal hypospadias.
Study design: Boys were eligible for this multicenter trial if they had a primary, single-stage repair of mid-to-distal hypospadias with placement of an open-drainage urethral stent for an intended duration of 5-10 days. Participants were randomized in a double-blind fashion to receive oral trimethoprim-sulfamethoxazole or placebo twice daily for 10 days postoperatively. The primary outcome was a composite of symptomatic UTI, surgical site infection (SSI), and urethroplasty complications, including urethrocutaneous fistula, meatal stenosis, and dehiscence. Secondary outcomes included each component of the primary outcome as well as acute adverse drug reactions (ADRs) and C. difficile colitis.
Results: Infection or urethroplasty complications occurred in 10 of 45 boys (22%) assigned to receive antibiotic prophylaxis as compared with 5 of 48 (10%) who received placebo (relative risk [RR], 2.1; 95% confidence interval [CI], 0.8 to 5.8; p = 0.16). There were no significant differences between groups in symptomatic UTIs, SSIs, or any urethroplasty complications. Mild ADRs occurred in 3 of 45 boys (7%) assigned to antibiotics as compared with 5 of 48 (10%) given placebo (RR, 0.6; 95% CI, 0.2 to 2.5; p = 0.72). There were no moderate-to-severe ADRs, and no patients developed C. difficile colitis.
Conclusions: In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid-to-distal hypospadias repair. The study did not reach its desired sample size and was therefore underpowered to independently support a conclusion that prophylaxis is not beneficial. However, the result is consistent with most prior research on this subject.
Gov identifier: NCT02096159
A review of currently available vessel sealing systems.
Laparoscopic surgery is rapidly expanding among urologists as a minimally invasive treatment with surgical procedures becoming increasingly challenging. Accurate haemostatis is of utmost importance in laparoscopy, as bleeding can rapidly impair the working environment conditions. We subsequently reviewed the different haemostatic tools used in laparoscopy with the focus on ultrasonic dissectors and electrothermal bipolar vessel sealer (EBVS). Briefly, there is a wide variety of haemostatic tools currently available in laparoscopy, all with their inherent advantages and limitations. The comparison of ultrasonic dissectors and EBVS shows that both systems are very attractive with similar physical properties concerning thermal spread and bursting pressure of vessels sealed. It has to be noted, however, that EBVS can handle vessels of up to 7 mm. In conclusion, haemostatic tools constitute a rapidly evolving domain with devices being developed which cause less thermal spread, while being more precise and faster. This evolution should finally allow more complex laparoscopic surgical procedures.Journal ArticleReviewinfo:eu-repo/semantics/publishe