2-octyl Cyanoacrylate for Closure of Urethrocutaneous Fistula.
Condition: Urethrocutaneous Fistulas
MeSH terms: Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      Urethrocutaneous fistulae (UCF) 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%. The surgical repair
      of UCF remains the treatment of choice, even if some patients need further operations because
      of recurrences. The 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.
    

Detailed description: 
      Design Randomized clinical trial carried out in children with UCF that occurred after
      hypospadias repair. The patients will be assign to either the control or study groups.

      The study group will include children with long-standing UCF that occurred at least 6 months
      after the initial intervention. After preparation of the fistula area, multiple layers of OCA
      will be apply, attaching the edges of the orifice. The same procedure will be repeated three
      times and the children will be follow for at least 6 months after treatment.

      The control group will include children with long-standing UCF that occurred at least 6
      months after the initial intervention. Patients will be scheduled for surgical treatment and
      will be follow for at least 6 months after surgery. If UCF recurred, a new intervention will
      be proposed.

      The sample size was determined based on a prevalence of the complication (UCF) of 25% in the
      surgery group and 70% in the medically treated group, given a confidence level of 95% and a
      power of 0.20, which resulted in a minimum sample size of 18 patients per group.

      The independent variables are the application of OCA in the UCF orifice or surgical treatment
      of UCF and the main outcome variable is FC without recurrence within at least 12 months
      follow-up. As confounding variables, we considered the children's age, the fistulous orifice
      diameter and the type of initial surgical procedure to which all were submitted.

      Procedure Assignment of patients to groups will be performed by using a sealed envelope
      chosen randomly by the father, mother or guardians. To decrease the inflammatory response and
      edema, patients in the study group will be instructed to apply triamcinolone cream to the
      fistula four times a day for 3 days. Once this treatment is completed, the patient will
      attended our clinic as an outpatient to undergo, after sedation with midazolam (0.5 mg/kg
      orally), Foley catheterization with a 10 Fr gauge siliconized catheter, with the balloon
      inflated with 1.5 ml water to prevent bladder spasm. Subsequently, we will apply an adhesive
      using dissecting forceps to approximate the edges of the UCF, and then applied several thin
      layers of OCA.

      The urethral catheter will be left in place for 5 days. At the end of this time, we will
      evaluate the closure or persistence of the UCF. If the UCF persist, the OCA adhesive will be
      apply twice following the same protocol before the medical procedure was deemed to have
      failed.

      Patients in the control group will wait 6 months to be treated surgically. The reoperation
      consist on mobilizing dartos flaps and closing the defect in layers with absorbable sutures.
      Urinary bladder drainage will be provide with a 10 Fr silicone Foley catheter, with the
      balloon inflated with 1.5 ml water to prevent bladder spasm. The follow-up time will be 12
      months for each group.

      Statistical analysis Statistical analysis Statistical software, SPSS for IBM (version 20 for
      Windows; IBM Corp., Armonk, NY, USA) is being used for data analysis.

      The data obtained will be expressed as frequencies and percentages, means and standard
      deviations. For comparing results, Student's t test will be used for continuous variables and
      Chi2 or Fisher's exact tests will be used for qualitative data when appropriate.

      Relative risk (RR) and 95% confidence intervals (95% CI) will be determined as well as the
      absolute risk reduction (ARR), relative risk reduction (RRR), and number needed to treat
      (NNT).

      Statistical significance from two-tailed tests was assumed when p < 0.05
    

Intervention name(s): 2-octylcyanoacrylate; Surgical reintervention
Intervention type(s): Device; Procedure
Intervention description(s): After sedation with midazolam (0.5 mg/kg orally) a Foley catheterization with a 10 Fr gauge siliconized catheter will be placed, with the balloon inflated with 1.5 ml water to prevent bladder spasm. After this we will apply the adhesive by using dissecting forceps to approximate the edges of the UCF, and then apply it several thin layers of OCA.; The reoperation will consist on mobilizing dartos flaps and closing the defect in layers with absorbable sutures. Urinary bladder drainage will be provided with a 10 Fr silicone Foley catheter, with the balloon inflated with 1.5 ml water to prevent bladder spasm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 2-octylcyanoacrylate; Urethrocutaneous fistulas.; Closure.; Recurrence.