HypospadiasFGTIP-TIPNCT02497963
Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP)
A study testing Foreskin Graft-Tubularized Incised Plate and Tubularized Incised Plate in people with Hypospadias, run by Hospital Infantil de Mexico Federico Gomez.
Trial summary
The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. Read more about this study
- Who is it for?
- Ages 3 months to 18 years, men only
- Conditions the study is for
- Hypospadias
- What is being tested?
- Foreskin Graft-Tubularized Incised Plate and Tubularized Incised Plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2017
- Phase
- Interventional
- 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 3 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with hypospadias without previous surgery
- Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.
Who cannot join
- Patients diagnosed with hypospadias and severe psychomotor development delay
- Patients with disorders of sexual development without gender assignment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.
Read the detailed description
Urethroplasty technique more used in the world for hypospadias repair is Tubularized Incised Plate described by Snodgrass in 1994. Kolon and Gonzales described a technical modification to the TIP in 2000, which is called grafting foreskin.
There are characteristics of the glans and urethral plate favoring the development of complications. In this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: TIP vs FG-TIP.
The main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of TIP vs FG-TIP.
The study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups.
The sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. The main outcome is complications.
- Conditions
- Hypospadias
- Being tested
- Foreskin Graft-Tubularized Incised Plate, Tubularized Incised Plate
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foreskin Graft-Tubularized Incised PlateProcedure or surgery
TIP Urethroplasty with foreskin graft in primary hypospadias
Tubularized Incised PlateProcedure or surgery
TIP Urethroplasty without foreskin graft in primary hypospadias
| Study group | Role | What they receive |
|---|---|---|
| Foreskin Graft-Tubularized Incised Plate | Experimental | Group of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter. Receives: Procedure: Foreskin Graft-Tubularized Incised Plate |
| Tubularized Incised Plate | Active comparator | Group of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter. Receives: Procedure: Tubularized Incised Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with complications as a measure of safety
Measured: Fourth month after surgery
Secondary outcomes (3)
Proportion of participants with fistula as a measure of safety
Measured: Fourth month after surgery
Proportion of participants with stricture as a measure of safety
Measured: Fourth month after surgery
Proportion of participants with breakdown as a measure of safety
Measured: Fourth month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Mario E Rendón Macías, MD MsC, Study chair, CMNXXI, IMSSOnofre Muñoz Hernández, MD MsC, Study director, Hospital Infantil de Mexico Federico Gomez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497963
- Sponsor's protocol ID
- HIM 2015-079
- Acronym
- FGTIP-TIP
- Status last verified
- Jul 2015
- First submitted
- 25 Jun 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Snodgrass WT. Re: Effect of suturing technique and urethral plate characteristics on complication rate following hypospadias repair: a prospective randomized study O. Sarhan, M. Saad, T. Helmy and A. Hafez J Urol 2009; 182: 682-686. J Urol. 2010 Apr;183(4):1649-50; discussion 1650. doi: 10.1016/j.juro.2009.12.048. Epub 2010 Mar 4. No abstract available.
PubMed 20206364Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. doi: 10.1016/s0022-5347(17)34991-1.
PubMed 8283561Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3.
PubMed 10799234Holland AJ, Smith GH. Effect of the depth and width of the urethral plate on tubularized incised plate urethroplasty. J Urol. 2000 Aug;164(2):489-91.
PubMed 10893631Mouravas V, Filippopoulos A, Sfoungaris D. Urethral plate grafting improves the results of tubularized incised plate urethroplasty in primary hypospadias. J Pediatr Urol. 2014 Jun;10(3):463-8. doi: 10.1016/j.jpurol.2013.11.012. Epub 2013 Dec 10.
PubMed 24360521
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)
- ClinicalTrials.gov ID
- NCT02497963
- Acronym / sponsor ID
- FGTIP-TIP / HIM 2015-079
- Conditions
- Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 15 Jul 2015 (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.
The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.
Detailed description
Urethroplasty technique more used in the world for hypospadias repair is Tubularized Incised Plate described by Snodgrass in 1994. Kolon and Gonzales described a technical modification to the TIP in 2000, which is called grafting foreskin.
There are characteristics of the glans and urethral plate favoring the development of complications. In this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: TIP vs FG-TIP.
The main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of TIP vs FG-TIP.
The study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups.
The sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. The main outcome is complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foreskin Graft-Tubularized Incised Plate | Experimental | Procedure: Foreskin Graft-Tubularized Incised PlateGroup of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter. |
| Tubularized Incised Plate | Active comparator | Procedure: Tubularized Incised PlateGroup of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with hypospadias without previous surgery
- Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.
Key exclusion criteria (2 listed)
- Patients diagnosed with hypospadias and severe psychomotor development delay
- Patients with disorders of sexual development without gender assignment
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 |
|---|---|---|
| Foreskin Graft-Tubularized Incised PlateTIP Urethroplasty with foreskin graft in primary hypospadias | Procedure or surgery | Foreskin Graft-Tubularized Incised Plate |
| Tubularized Incised PlateTIP Urethroplasty without foreskin graft in primary hypospadias | Procedure or surgery | Tubularized Incised Plate |
Primary outcome
Proportion of participants with complications as a measure of safety
Time frame: Fourth month after surgery
3 secondary outcomes
Proportion of participants with fistula as a measure of safety
Time frame: Fourth month after surgery
Proportion of participants with stricture as a measure of safety
Time frame: Fourth month after surgery
Proportion of participants with breakdown as a measure of safety
Time frame: Fourth month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Background: PubMed 20206364Snodgrass WT. Re: Effect of suturing technique and urethral plate characteristics on complication rate following hypospadias repair: a prospective randomized study O. Sarhan, M. Saad, T. Helmy and A. Hafez J Urol 2009; 182: 682-686. J Urol. 2010 Apr;183(4):1649-50; discussion 1650. doi: 10.1016/j.juro.2009.12.048. Epub 2010 Mar 4. No abstract available.
- Results publication: PubMed 8283561Snodgrass W. Tubularized, incised plate urethroplasty for distal hypospadias. J Urol. 1994 Feb;151(2):464-5. doi: 10.1016/s0022-5347(17)34991-1.
- Results publication: PubMed 10799234Kolon TF, Gonzales ET Jr. The dorsal inlay graft for hypospadias repair. J Urol. 2000 Jun;163(6):1941-3.
- Results publication: PubMed 10893631Holland AJ, Smith GH. Effect of the depth and width of the urethral plate on tubularized incised plate urethroplasty. J Urol. 2000 Aug;164(2):489-91.
- Results publication: PubMed 24360521Mouravas V, Filippopoulos A, Sfoungaris D. Urethral plate grafting improves the results of tubularized incised plate urethroplasty in primary hypospadias. J Pediatr Urol. 2014 Jun;10(3):463-8. doi: 10.1016/j.jpurol.2013.11.012. Epub 2013 Dec 10.
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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.
Mario E Rendón Macías, MD MsC study chair
CMNXXI, IMSS
Onofre Muñoz Hernández, MD MsC study director
Hospital Infantil de Mexico Federico Gomez
Questions about this trial
What is this clinical trial studying?
A study testing Foreskin Graft-Tubularized Incised Plate and Tubularized Incised Plate in people with Hypospadias, run by Hospital Infantil de Mexico Federico Gomez.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byron A Pacheco Mendoza, MD MsC (+525544378709, byronpachecom@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with complications as a measure of safety (time frame: Fourth month after surgery). 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 NCT02497963, which also lists 5 linked publications.
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 15 Jul 2015.