title: 2-octyl cyanoacrylate versus reintervention for closure of urethrocutaneous fistulae after urethroplasty for hypospadias: a randomized controlled trial.
abstract: BACKGROUND
  Urethrocutaneous 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02115191. Date: April 13, 2014.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Ambriz-González
authors.forename: Pedro
authors.initials: P
authors.lastname: Aguirre-Ramirez
authors.forename: José Manuel
authors.initials: JM
authors.lastname: García-de León
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: León-Frutos
authors.forename: Sergio Adrián
authors.initials: SA
authors.lastname: Montero-Cruz
authors.forename: Xóchitl
authors.initials: X
authors.lastname: Trujillo
authors.forename: Clotilde
authors.initials: C
authors.lastname: Fuentes-Orozco
authors.forename: Michel Dassaejv
authors.initials: MD
authors.lastname: Macías-Amezcua
authors.forename: Andrea
authors.initials: A
authors.lastname: del Socorro Álvarez-Villaseñor
authors.forename: Ana Olivia
authors.initials: AO
authors.lastname: Cortés-Flores
authors.forename: Mariana
authors.initials: M
authors.lastname: Chávez-Tostado
authors.affiliation: Research Unit in Clinical Epidemiology, Medical Unit of High Specialty, Specialties Hospital of the Western Medical Center, Mexican Institute of Social Security, Avenida Belisario Domínguez 1000, Colonia Independencia, CP 44340 Guadalajara, Jalisco, México. avygail5@yahoo.com.mx.
authors.forename: Alejandro
authors.initials: A
authors.lastname: González-Ojeda
mesh_terms: D002648:Child; D002675:Child, Preschool; D017577:Cutaneous Fistula / Q000628:therapy*; D003487:Cyanoacrylates / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D007021:Hypospadias / Q000601:surgery*; D007223:Infant; D008297:Male; D012086:Reoperation; D014014:Tissue Adhesives / Q000627:therapeutic use*; D016896:Treatment Outcome; D014521:Urethra / Q000601:surgery*; D014522:Urethral Diseases / Q000628:therapy*; D014548:Urinary Fistula / Q000628:therapy*
chemical_list: D003487:Cyanoacrylates; D014014:Tissue Adhesives; C100832:octyl 2-cyanoacrylate