Isoamyl 2-cyanoacrylate interposition in the urethro-cutaneous fistula repair: A randomized controlled trial

Abstract
Background
We aim to evaluate isoamyl 2-cyanoacrylate as an intervening layer in the surgical repair of the urethra-cutaneous fistula (UCF) after hypospadias in comparison with the classic surgical repair technique.

Methods
Between January 2017 and July 2018, 40 patients with UCF were randomized into two equal groups. Group I represented a multilayered closure with dartos fascia flap while using cyanoacrylate glue as an interposition layer, while group II represented the same procedure without applying the glue. We followed up our patients for 6 months following the procedure to evaluate a successful closure.

Results
Forty patients were available for evaluation at the end of our study. There was no statistically significant difference between the two groups regarding their demographic data. The mean fistula size was 3.25 ± 0.64 and 3.15 ± 0.75 mm in group I and II, respectively, with a statistically significant difference. Successful UCF closure was achieved in 80% of cases in group I (16/20) and 70% of group II (14/20) with no statistically significant difference. There was no statistically significant difference between both groups as regards the occurrence of mild complications in the postoperative period, which was 10% in both groups.

Conclusion
The application of cyanoacrylate during UCF repair was feasible and safe. The successful repair of UCF was found to be higher with cyanoacrylate. However, we could not demonstrate a statistically significant difference between the two groups.
Trial registration number The trial is registered at clinicaltrial.gov with trial registration number: NCT04876976 (retrospective registration)