A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias

Purpose: Hypospadias repair is a common operation performed by pediatric ur ologists. Perhaps the greatest variable and source of controversy of postop erative care is the surgical dressing. We hypothesized that using no dressi ng would achieve surgically comparable results to those traditionally achie ved by a postoperative dressing and it would also simplify postoperative pa rent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hyp ospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. Materials and Methods: In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proxima l and 60 with distal hypospadias on an outpatient basis. Ethics and Interna l Review Board approval, and informed consent were obtained. Boys were then postoperatively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on pos toperative care were distributed to all families and a questionnaire was di stributed to the parents at the initial followup. Surgical outcome was eval uated and questionnaire responses were analyzed. Fisher's exact test was do ne to test the significance of differences in surgical outcomes and questio nnaire responses. Results: A total of 117 boys completed the prospective randomized trial. Su rgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 181 questionnaires for response analysis. The type or absence of the dressing did not correlate with the ne ed for repeat procedures, urethrocutaneous fistula, or meatal stenosis or r egression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fel low. These findings were statistically significant. In addition, there were more unscheduled visits to the urology clinic, emergency room or primary p hysician office by boys with than without a dressing. Furthermore, 29% of t he parents were not psychologically prepared to remove the dressing and 12% were so reluctant that the dressing was removed at the urology outpatient clinic. Conclusions: The surgical outcome and rate of adverse events or complicatio ns were not compromised without a postoperative dressing. An absent dressin g simplified postoperative ambulatory parent delivered home care. We recomm end that dressings should be omitted from routine use after hypospadias rep air.