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

BMC Urology

Research Article

Andrea del Socorro Álvarez-Villaseñor¹  Gabriela Ambriz-González²  José Manuel García-de León²  Pedro Aguirre-Ramirez³  Francisco Javier León-Frutos⁴  Michel Dassaejv Macías-Amezcua⁵  Clotilde Fuentes-Orozco⁵  Ana Olivia Cortés-Flores⁵  Mariana Chávez-Tostado⁵  Alejandro González-Ojeda⁵  Sergio Adrián Montero-Cruz⁶  Xóchilt Trujillo⁶ 

[1] Coordination of Health Research, Mexican Institute of Social Security, La Paz, Baja California Sur, Mexico;Pediatrics Surgery Department, Medical Unit of High Specialty, Pediatrics Hospital of the Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico;Pediatrics Urology Department, Medical Unit of High Specialty, Pediatrics Hospital of the Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico;Pediatrics Urology Department, Medical Unit of High Specialty, Pediatrics Hospital of the Western Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, Mexico;Private practice, Guadalajara, Jalisco, Mexico;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, Mexico;Universitary Center of Biomedical Research, University of Colima, Colima, Colima, Mexico;

关键词: Hypospadias;    Urethrocutaneous fistula;    2-Octyl cyanoacrylate;    Fistula repair;   

DOI  :  10.1186/1471-2490-14-93

 received in 2014-04-16, accepted in 2014-11-10,  发布年份 2014

来源: Springer

【 摘 要 】

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.

【 授权许可】

Unknown   
© Ambriz-González et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.