Comparison of complications of distal hypospadias repair with and without the use of postoperative prophylactic IV antibiotics: A randomized controlled trial

Technical Summary: Comparison of Complications in Distal Hypospadias Repair With and Without Postoperative Prophylactic IV Antibiotics

Problem Statement
Distal hypospadias is a common congenital anomaly affecting 3–5 per 1,000 male births, requiring surgical repair to ensure optimal urinary and sexual function. Despite advancements in techniques like tabularised incised plate urethroplasty (TIP), postoperative complications such as surgical site infections (SSI), urinary tract infections (UTI), wound dehiscence, urethrocutaneous fistula (UCF), and meatal stenosis remain significant concerns. A specific area of debate in postoperative management is the necessity of prophylactic intravenous (IV) antibiotics, particularly when a urethral stent is placed. While some guidelines (e.g., American Urological Association) suggest prophylaxis for stented procedures, others (e.g., CDC) advise against additional antimicrobials after wound closure in clean-contaminated surgeries. Currently, there is no standardized, evidence-based clinical guideline specifically addressing postoperative antibiotic prophylaxis for pediatric distal hypospadias repair, leading to variable practices among clinicians.

Methodology
This study was a randomized controlled trial (RCT) conducted at King Edward Medical University/Mayo Hospital, Lahore, between September 2024 and May 2025.

• Participants: 60 male patients, aged up to 12 years, undergoing TIP with stent placement for distal penile hypospadias. Exclusion criteria included redo urethroplasty, malnutrition, comorbidities (liver disease, TB, immunodeficiency).
• Intervention: Patients were randomly assigned (1:1 ratio) into two groups:
  • Group A (n=30): Received preoperative IV Ceftriaxone (25mg/kg) followed by postoperative prophylactic IV antibiotics (Co-amoxiclav 30mg/kg TID and Amikacin 7.5mg/kg BID) for 5 days until stent removal.
  • Group B (n=30): Received preoperative IV Ceftriaxone (25mg/kg) but no postoperative prophylactic antibiotics.
• Procedure: All surgeries were performed under general anesthesia by senior registrars or consultants using Vicryl 5-0 sutures.
• Outcomes: Complications were assessed at discharge, day 15, and day 30. Primary outcomes included UTI, SSI, wound dehiscence, meatal stenosis, and UCF. Data were analyzed using SPSS version 23.0, employing Chi-Square and Fisher's Exact tests (p ≤ 0.05 considered significant).

Key Results
The study found no statistically significant difference in complication rates between the two groups:

• Infection-Related Complications:
  • UTI: 2/30 (6.67%) in Group A vs. 1/30 (3.33%) in Group B (p > 0.99).
  • SSI: 3/30 (10%) in Group A vs. 4/30 (13.3%) in Group B (p > 0.99).
  • Combined Infection Rate: 5/30 (16.7%) in both groups (p > 0.99).
• Wound-Related Complications:
  • Urethrocutaneous Fistula (UCF): 2/30 (6.7%) in both groups.
  • Meatal Stenosis: 1/30 (3.3%) in Group A vs. 2/30 (6.67%) in Group B (p > 0.99).
  • Wound Dehiscence: 0 cases in either group.
• Overall Complication Rates: Group A had 8/30 (26.6%) complications, while Group B had 9/30 (30%) complications.

Key Contributions

• Evidence-Based Guidance: This RCT provides specific data challenging the routine use of postoperative IV antibiotics in distal hypospadias repair with stents, a practice not currently standardized in pediatric urology.
• Alignment with Broader Guidelines: The findings support CDC guidelines that advise against postoperative antibiotics for clean-contaminated surgeries after closure, even with drains or stents, while highlighting the lack of specific pediatric evidence supporting the American Urological Association's broader recommendations.
• Differentiation of Complication Drivers: The study demonstrates that major long-term morbidities like UCF are likely driven by surgical technique and tissue handling rather than infection, as antibiotic use did not reduce fistula rates.

Significance and Claims
The paper concludes that routine postoperative IV antibiotics do not significantly reduce overall complication rates in distal hypospadias repair. While a slight, non-significant reduction in infection-related complications was numerically observed in the antibiotic group, the authors argue that the data does not justify the universal administration of postoperative IV antibiotics.

The authors claim that the primary drivers of surgical failure (specifically UCF) are non-infectious factors, emphasizing that meticulous surgical technique and individualized care are more critical to optimizing outcomes than prophylactic antibiotics. The study advocates for a shift toward a more selective approach to antibiotic prescribing to mitigate antimicrobial resistance and avoid unnecessary drug exposure in children. The authors modestly suggest that while their findings support withholding routine prophylaxis, larger multicenter trials with longer follow-up are necessary to validate these results and identify specific subgroups (e.g., immunocompromised patients) who might still benefit from antibiotic regimens.