RESUMO
Background and objective Tubularized incised plate (TIP) urethroplasty is an easy and popular technique for repairing hypospadias, however urethrocutaneous fistula (UCF) is a frequently reported complication. Different techniques are used to reduce this complication. We aimed to compare the rate of UCF after single dartos and double dartos TIP urethroplasty in children with distal and mid penile hypospadias. Methods A randomized controlled trial (NCT04699318) was conducted in the Department of Pediatric Surgery, Mayo Hospital, Pakistan from August 2017 to February 2018, after ethical approval. After informed consent, a total of 60 patients with distal and mid penile hypospadias who were uncircumcised, had no chordee, and/or previous surgery, were randomly allocated in two groups using computer generated table numbers. Group A underwent single dartos TIP urethroplasty and Group B underwent double dartos TIP urethroplasty. Catheter was removed on day 10 post-operatively in both groups and primary outcome (UCF) was noted after a week of catheter removal. Rate of UCF was compared using chi square and p-value of <0.05 was taken as significant. Data was stratified to check for effect modifiers. Results Out of 60 children, eight (13.3%) developed UCF. In Group A, seven (23.3%) developed UCF and in Group B, one (3.3%) developed UCF (p-value 0.02). In both groups, no patient (0%) had urethral disruption, penile torsion, skin necrosis or meatal stenosis. Conclusion Additional covering of neo-urethra by a double dartos layer significantly reduces fistula rate after tubularized incised plate urethroplasty in both primary distal and mid penile hypospadias.