2-octyl cyanoacrylate versus reintervention for closure of urethrocutaneous fistulae after urethroplasty for hypospadias: a randomized controlled trial

Abstract

BackgroundUrethrocutaneous fistulae (UCFs) represent one of the most frequent causes of morbidity after urethroplasty. Hypospadias can be repaired using different surgical techniques, but—regardless of technique—the incidence of UCF ranges between 10% and 40%. Surgical repair of UCF remains the treatment of choice, even if some patients need further surgery because of recurrences. Cyanoacrylates have been used as skin suture substitutes, and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF. Here we describe the results of management of UCF using 2-octyl cyanoacrylate (OCA) compared with surgical repair.MethodsA randomized clinical trial conducted from January 2008 to December 2012 included 42 children with UCF complications after urethroplasty for hypospadias. Twenty-one children were assigned to receive OCA as ambulatory patients and 21 were treated surgically. The main outcome variable was closure of the UCF. The estimated costs of both treatments were also calculated, as were absolute risk reduction (ARR), relative risk reduction (RRR) and number needed to treat (NNT) to prevent a surgical intervention.ResultsThe mean numbers of UCF were 1.3 in the OCA group (n = 28) and 1.1 in the surgical group (n = 25) with no statistically significant difference. The external orifices measured were 2.96 ± 1.0 mm and 3.8 ± 0.89 mm, respectively (NS). Sixty per cent of the UCFs treated with cyanoacrylate were completely closed and 68% of the surgical group healed completely (NS). More than one reoperation to improve complications was needed in the surgical group (3.5 ± 1.2). The clinical significance of the therapeutic usefulness of OCA was demonstrated by an ARR of 0.08, RRR of 0.25 and NNT of 12 to avoid further surgical treatment. The total costs of adhesive applications and reoperations were $US 14,809.00 and $US 158,538.50, respectively.ConclusionsThe results showed a similar success rate for both treatments. However, sealant use should be considered before surgical treatment because this is a simple outpatient procedure with a reasonable success rate.Trial registrationClinicalTrials.gov Identifier: NCT02115191. Date: April 13, 2014.

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

“…Despite the various modifications employed by surgeons in hypospadias surgical repair to achieve successful urethral closure, UCF remains one of the most bothersome postoperative complications [13]. UCF incidence was 0.5% to 10% for the meatal advancement and glanuloplasty technique and up to 5-11% for tubularization procedures, while it reached up to 15-35% for free grafttubed repair [6,[14][15][16].…”

“…UCF usually occurs in the weak points of the reconstructed urethral tube due to several etiologies as an inadequate cicatrization process, distal stenotic segment of the urethra or due to infective processes especially with the insufficient blood supply to the repaired areas [17,18]. Some small fistulas can close spontaneously in the first few months following surgical repair [12].…”

“…Various surgical techniques may be used in the attempt of UCF repair including multilayer simple closure technique, rotational dartos or skin flaps, and advancement flaps which may be used to enhance fistula closure. Nonetheless, the risk of UCF recurrence still represents a challenge for surgeons despite multilayered closures [17,18].…”

“…In a study by Gopal et al, fibrin glue has been used as a sealant material in hypospadias surgery but did not eliminate fistula formation. However, it minimized its incidence [18,19]. Isoamyl 2-cyanoacrylate is an advanced tissue adhesive that is gamma sterilized and the properties of being nonpigmented, non-toxic, non-allergic, and biostatic.…”

“…Cyanoacrylate products have both waterproof and bacteriostatic properties, which allows their wide use for surgical wound primary closure, and it has been used to some extent in suture-less circumcision and pediatric lacerations. They have been used for the repair of UCF in outpatient settings as their tensile strength maintains an adequate contact of the fistula's edges leading to enhanced healing [11][12][13].…”