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Antibiotic prophylaxis and therapy do not reduce surgical or infectious complications in hypospadias urethroplastyTrial Shows Antibiotics Do Not Change Hypospadias Surgery Outcomes

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Key Takeaway
Note that antibiotic prophylaxis and therapy do not reduce the frequency of surgical or infectious complications in hypospadias.

This randomized trial enrolled 300 children with coronal hypspadias undergoing urethroplasty to evaluate the effectiveness of different antibiotic regimens. Participants were divided into three groups: Group I received a single intraoperative dose, Group II received intraoperative prophylaxis plus 10 days of therapy, and Group III received no antibiotics.

Primary outcomes focused on the effectiveness of antibiotic prophylaxis and therapy before, during, and after repair. Regarding secondary outcomes, the study found no statistical difference in urethral fistulas between groups (Group I: 2 (2%), Group II: 2 (2%), Group III: 4 (4%)). Additionally, no significant difference was observed in symptomatic urinary tract infections across the three groups (p=0.182).

Safety data regarding adverse events or tolerability were not reported. The study indicates that the duration and timing of antibiotic administration did not significantly alter the incidence of postoperative surgical complications or infections. These findings suggest that current antibiotic protocols may not provide additional protection against common complications in this specific surgical population.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap regarding the specific impact of antibiotic duration and prophylaxis on surgical outcomes in pediatric hypospadias repair. While other covered evidence notes that shorter-course antibiotic therapy is comparable to longer-course for children with acute uncomplicated UTIs, this study specifically examines the role of antibiotics in a surgical context for hypospadias. It does not relate to the CABU-EICO intervention bundle or the risks associated with antibiotic exposure in other conditions.

Researchers conducted a randomized trial to see how different antibiotic plans affected children undergoing surgery for coronal hypospadias. The study looked at 300 children who were divided into three groups. These groups received different amounts of antibiotics: one group received a single dose during surgery, one received a 10-day course of treatment, and one received no antibiotics at all.

The results showed that the type of antibiotic treatment did not change the rates of common complications. Specifically, there was no statistical difference in the number of urethral fistulas among the three groups. Additionally, the study found no significant difference in the number of symptomatic urinary tract infections regardless of the antibiotic plan.

Because the results were similar across all groups, the study suggests that adding more antibiotics does not necessarily reduce surgical complications or infections for this specific condition. Patients and parents can use this information to discuss surgical plans with their doctors. However, every child's case is unique, and medical decisions should always be made with a specialist.

What this means for you:
Different antibiotic protocols did not change the rate of infections or complications in children after surgery.

Common questions

Do antibiotics prevent infections after hypospadias surgery?

The study of 300 children found no significant difference in symptomatic urinary tract infections among the three groups. This means that whether a child received a single dose, a 10-day course, or no antibiotics during the procedure, the rates of infection remained similar. You should discuss these findings with your surgeon to determine the best plan for your child.

Does a longer course of antibiotics reduce surgical complications?

The study compared a 10-day antibiotic course to a single dose and no antibiotics. The results showed no statistical difference in the occurrence of urethral fistulas among the groups. This suggests that a longer course of antibiotics did not change the frequency of these specific surgical complications in the children studied.

What were the specific complications measured in the study?

The study measured several outcomes, including urethral fistulas, stenosis, and diverticulum. It also looked at wound infection symptoms like pain and redness. The results showed that the type of antibiotic treatment did not significantly change the frequency of these complications for children undergoing hypospadias repair.

Study Details

Study typeRct
Sample sizen = 300
EvidenceLevel 2
Follow-up6.0 mo
PublishedOct 2026
View Original Abstract ↓
BACKGROUND AND OBJECTIVE: Antibiotic resistance is a challenge in contemporary world. Urethroplasty for hypospadias is one of the most common urological surgeries performed around the world, yet, there is still no consensus on the use of antibiotics pre- and post-operatively. Our objective was to analyze the effectiveness of antibiotic prophylaxis and therapy before, during, and after hypospadias repair in children. METHODS: A prospective randomized trial was carried out including patients with coronal hypospadias who underwent urethroplasty performed by one surgeon. Urethral catheters were used in all cases for 10 days. Study participants were randomly assigned in a 1:1:1 ratio to receive a single intraoperative administration of antibiotics (Group I); an intraoperative antibiotic prophylaxis and antibiotic therapy for 10 days until the removal of urethral catheter (Group II); no antibiotic administration (Group III). Randomization was performed using computer-generated permuted blocks with randomly varying block sizes, prepared by an independent statistician. The results were analyzed using the analysis of variance (ANOVA). The following criteria were compared: postoperative functional complications, such as: urethral fistula, stenosis, diverticulum; wound infection symptoms: hyperemia of surgical site, pain during palpation, and symptomatic urinary tract infection. RESULTS: A total of 300 patients were included in the study. Two patients (2%) in Group I, two patients (2%) in Group II, and four patients (4%) in Group III had urethral fistulas, requiring surgery 6 months after primary repair, yet without statistical difference between groups. We found no significant difference in frequency of symptomatic UTIs between three groups (p = 0.182). CONCLUSION: There is no effect of antibiotic prophylaxis and therapy on the frequency of postoperative surgical and infectious complications after urethroplasty for coronal hypospadias repair in children.
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