Urethrocutaneous FistulasPhase 3NCT02115191
2-octyl Cyanoacrylate for Closure of Urethrocutaneous Fistula.
A Phase 3 study testing 2-octylcyanoacrylate and Surgical reintervention in people with Urethrocutaneous Fistulas, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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%. Read more about this study
- Who is it for?
- Ages 6 months to 5 years, men only
- Conditions the study is for
- Urethrocutaneous Fistulas
- What is being tested?
- 2-octylcyanoacrylate and Surgical reintervention
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children younger than 5 years old with at least one postoperative UCF with an external orifice less than 5 mm in diameter at the distal, proximal or medial penis,
- Patients whose parents or guardians accepted inclusion in the study by signing the informed consent form
Who cannot join
- Patients with an external orifice more than 5 mm in diameter
- Iatrogenic or traumatic fistulae
- The presence of obstruction distal to the fistula, necrotic tissue or active infection at the surgical site,
- The presence of chronic diseases such as diabetes mellitus, renal or hepatic insufficiency, malignancy of any type or use of steroids and/or immunosuppressive therapy of any kind,
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Department of Pediatric Surgery of the Pediatrics Hospital of the Western Medical Center of the Mexican Institute of Social Security
Guadalajara, Jalisco, 44340
About this study
Official title: Use of 2-octylcyanoacrylate for Closure Urethrocutaneous Fistulas After Urethroplasty for Hypospadias
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.
Read the 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
- Conditions
- Urethrocutaneous Fistulas
- Being tested
- 2-octylcyanoacrylate, Surgical reintervention
- Keywords
- 2-octylcyanoacrylate, Urethrocutaneous fistulas., Closure., Recurrence.
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-octylcyanoacrylateDevice
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.
Surgical reinterventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 2-octylcyanoacrylate | Experimental | Application of 2-octylcyanoacrylate Receives: Device: 2-octylcyanoacrylate |
| Surgical reintervention | Active comparator | Surgical reintervention for urethrocutaneous fistula repair Receives: Procedure: Surgical reintervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias.
Closure or recurrence of urethrocutaneous fistulas after cyanoacrylate application or surgical intervention.
Measured: 12 months after procedure.
Secondary outcomes (1)
Morbidity after applications
Morbidity after applications of cyanoacrylates or surgical reintervention.
Measured: 12 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urethrocutaneous FistulasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Mexicano del Seguro Social
- Sponsor type
- Other government
- Responsible party
- Principal investigator, GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social
- Investigators
- Alejandro González-Ojeda, Ph.D., M.D., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115191
- Sponsor's protocol ID
- Cyanoacrylate-2014-03
- Status last verified
- Sep 2023
- First submitted
- 13 Apr 2014
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ambriz-Gonzalez G, Aguirre-Ramirez P, Garcia-de Leon JM, Leon-Frutos FJ, Montero-Cruz SA, Trujillo X, Fuentes-Orozco C, Macias-Amezcua MD, del Socorro Alvarez-Villasenor A, Cortes-Flores AO, Chavez-Tostado M, Gonzalez-Ojeda A. 2-octyl cyanoacrylate versus reintervention for closure of urethrocutaneous fistulae after urethroplasty for hypospadias: a randomized controlled trial. BMC Urol. 2014 Nov 21;14:93. doi: 10.1186/1471-2490-14-93.
PubMed 25416602
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 2-octylcyanoacrylate for Closure Urethrocutaneous Fistulas After Urethroplasty for Hypospadias
- ClinicalTrials.gov ID
- NCT02115191
- Acronym / sponsor ID
- Cyanoacrylate-2014-03
- Conditions
- Urethrocutaneous Fistulas
- Keywords
- 2-octylcyanoacrylate, Urethrocutaneous fistulas., Closure., Recurrence.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Instituto Mexicano del Seguro SocialOther government
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-octylcyanoacrylate | Experimental | Device: 2-octylcyanoacrylateApplication of 2-octylcyanoacrylate |
| Surgical reintervention | Active comparator | Procedure: Surgical reinterventionSurgical reintervention for urethrocutaneous fistula repair |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children younger than 5 years old with at least one postoperative UCF with an external orifice less than 5 mm in diameter at the distal, proximal or medial penis,
- Patients whose parents or guardians accepted inclusion in the study by signing the informed consent form
Key exclusion criteria (4 listed)
- Patients with an external orifice more than 5 mm in diameter
- Iatrogenic or traumatic fistulae
- The presence of obstruction distal to the fistula, necrotic tissue or active infection at the surgical site,
- The presence of chronic diseases such as diabetes mellitus, renal or hepatic insufficiency, malignancy of any type or use of steroids and/or immunosuppressive therapy of any kind,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-octylcyanoacrylateAfter 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. | Device | 2-octylcyanoacrylate |
| Surgical reinterventionThe 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. | Procedure or surgery | Surgical reintervention |
Primary outcome
Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias.
Time frame: 12 months after procedure.
Closure or recurrence of urethrocutaneous fistulas after cyanoacrylate application or surgical intervention.
1 secondary outcome
Morbidity after applications
Time frame: 12 months after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 25416602Ambriz-Gonzalez G, Aguirre-Ramirez P, Garcia-de Leon JM, Leon-Frutos FJ, Montero-Cruz SA, Trujillo X, Fuentes-Orozco C, Macias-Amezcua MD, del Socorro Alvarez-Villasenor A, Cortes-Flores AO, Chavez-Tostado M, Gonzalez-Ojeda A. 2-octyl cyanoacrylate versus reintervention for closure of urethrocutaneous fistulae after urethroplasty for hypospadias: a randomized controlled trial. BMC Urol. 2014 Nov 21;14:93. doi: 10.1186/1471-2490-14-93.
Related trials for Urethrocutaneous Fistulas
Recruiting
Effect of Caudal Block on Urethrocutaneous Fistula After Distal Hypospadias Repair
Hypospadias, Caudal Block
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro González-Ojeda, Ph.D., M.D. principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2-octylcyanoacrylate and Surgical reintervention in people with Urethrocutaneous Fistulas, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias. (time frame: 12 months after procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.