Penile HypospadiasNCT05528276
Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?
A study testing Repair surgery in people with Penile Hypospadias, run by Assiut University at 1 site in Egypt.
Trial summary
Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men only
- Conditions the study is for
- Penile Hypospadias
- What is being tested?
- Repair surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2022to 29 Oct 2024
- 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 1 year to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children age more than 12 months to 12 years.
- De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)
Who cannot join
- Circumcised
- Ventral Penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate).
- Uretheral plate less than 6mm
- Megameatus intact prepuce
- Albumin less than 3.5 g/dL
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university hospital
Asyut, 71515
abdelrahman M abdelkader, 01068336396, abdelrahmanmohamed.aa@aun.edu.eg
About this study
Official title: Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.
Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate \& good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.
- Conditions
- Penile Hypospadias
- Being tested
- Repair surgery
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair surgeryProcedure or surgery
- a circumscribing skin incision was made 2 mm below the hypospadias meatus,
- penile degloving,
- the para-urethral plate incision was made,
- A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans.
- The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture.
- The neomeatus was formed on a catheter 2 F larger than the urethral stent.
- A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty.
- A suitable urethral stent was left in situ for 7-10 days, with a compressive dressing applied.
- Grafted tubularised incised-plate .
1.Same steps but adding a graft (dorsal inlay) , 2. The graft will be taken from the inner preputial skin . 3. The graft will be sutured to overlying plate incision line from the old meatus to the tip of the glans.
| Study group | Role | What they receive |
|---|---|---|
| standard Tubularized incised plate urethroplasty (sTIPU) | Active comparator | Not described Receives: Procedure: Repair surgery |
| Preputial inlay graft urethroplasty (PIGU) | Active comparator | Not described Receives: Procedure: Repair surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time.
the duration of the operation will be measured from the start of anesthesia to end.
Measured: intraoperative
blood loss.
the amount of blood loss will be measured by CBC
Measured: one hour postoperatively
site of the meatus
the meatal position will be measured in centimeters from the original position .
Measured: 6 months from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start29 Aug 2022 (estimated)
- Primary completion29 Oct 2024 (estimated)
- Study completion29 Oct 2024 (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 Penile HypospadiasStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Mohamed Abdelkader, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528276
- Sponsor's protocol ID
- hypospadias repair
- Status last verified
- Sep 2022
- First submitted
- 28 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alshafei A, Cascio S, Boland F, O'Shea N, Hickey A, Quinn F. Comparing the outcomes of tubularized incised plate urethroplasty and dorsal inlay graft urethroplasty in children with hypospadias: a systematic review and meta-analysis. J Pediatr Urol. 2020 Apr;16(2):154-161. doi: 10.1016/j.jpurol.2020.01.009. Epub 2020 Jan 22.
PubMed 32061491Liu MM, Holland AJ, Cass DT. Assessment of postoperative outcomes of hypospadias repair with validated questionnaires. J Pediatr Surg. 2015 Dec;50(12):2071-4. doi: 10.1016/j.jpedsurg.2015.08.047. Epub 2015 Sep 1.
PubMed 26455467Pfistermuller KL, McArdle AJ, Cuckow PM. Meta-analysis of complication rates of the tubularized incised plate (TIP) repair. J Pediatr Urol. 2015 Apr;11(2):54-9. doi: 10.1016/j.jpurol.2014.12.006. Epub 2015 Feb 26.
PubMed 25819601Seleim HM, ElSheemy MS, Abdalazeem Y, Abdullateef KS, Arafa MA, Shouman AM, Elsaket H, Kaddah SN, Elbarbary MM. Comprehensive evaluation of grafting the preservable narrow plates with consideration of native plate width at primary hypospadias surgery. J Pediatr Urol. 2019 Aug;15(4):345.e1-345.e7. doi: 10.1016/j.jpurol.2019.05.002. Epub 2019 May 9.
PubMed 31155410Ahmed M, Alsaid A. Is combined inner preputial inlay graft with tubularized incised plate in hypospadias repair worth doing? J Pediatr Urol. 2015 Aug;11(4):229.e1-4. doi: 10.1016/j.jpurol.2015.05.015. Epub 2015 Jun 12.
PubMed 26119452
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05528276
- Acronym / sponsor ID
- hypospadias repair
- Conditions
- Penile Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 29 Aug 2022 (estimated)
- Primary completion
- 29 Oct 2024 (estimated)
- Study completion
- 29 Oct 2024 (estimated)
- First posted
- 6 Sep 2022 (actual)
- 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.
Hypospadias is a common congenital anomalies in male children affecting 1 in 200-300 male births, the penis urethral opening is found ventrally, penile curvature and a lack of foreskin (1). Multiple operations are described , Tubularised incised-plate is the preferred option for distal hypospadias and with trial to extend the operation indication to proximal and redo hypospadias (2). Its simple operative technique made TIP repair gain worldwide acceptance in addition to the low complication rate \& good cosmetic outcome (3).It has several complication as stenosis meatus, fistula formation , uretheral stricture and failed repair (4). Objective scoring systems were introduced to allow better judgment and identification of the postoperative results, depending on pre-operative and intra-operative criteria (5). Modifications of the T.I.P operation was done to reduce complication and allow better results by using a graft , Snodgraft vs Snodgrass operation are nearly equal regarding the outcomes (6). To our knowledge there is no definite recommendation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard Tubularized incised plate urethroplasty (sTIPU) | Active comparator | Procedure: Repair surgery |
| Preputial inlay graft urethroplasty (PIGU) | Active comparator | Procedure: Repair surgery |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children age more than 12 months to 12 years.
- De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)
Key exclusion criteria (5 listed)
- Circumcised
- Ventral Penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate).
- Uretheral plate less than 6mm
- Megameatus intact prepuce
- Albumin less than 3.5 g/dL
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 |
|---|---|---|
| Repair surgery1. a circumscribing skin incision was made 2 mm below the hypospadias meatus, 2. penile degloving, 3. the para-urethral plate incision was made, 4. A vertical midline incision of the urethral plate was made from within the hypospadiac meatus and extended up to the mid-glans. 5. The urethral plate was tubularised, beginning proximally, and closed in two layers using 6/0 polyglactin 910 suture. 6. The neomeatus was formed on a catheter 2 F larger than the urethral stent. 7. A flap was harvested from the prepuce to cover the neourethra and finally glanuloplasty. 8. A suitable urethral stent was left in situ for 7-10 days, with a compressive dressing applied. * Grafted tubularised incised-plate . 1.Same steps but adding a graft (dorsal inlay) , 2. The graft will be taken from the inner preputial skin . 3. The graft will be sutured to overlying plate incision line from the old meatus to the tip of the glans. | Procedure or surgery | Preputial inlay graft urethroplasty (PIGU), standard Tubularized incised plate urethroplasty (sTIPU) |
Primary outcome
Operation time.
Time frame: intraoperative
the duration of the operation will be measured from the start of anesthesia to end.
blood loss.
Time frame: one hour postoperatively
the amount of blood loss will be measured by CBC
site of the meatus
Time frame: 6 months from the operation
the meatal position will be measured in centimeters from the original position .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Background: PubMed 32061491Alshafei A, Cascio S, Boland F, O'Shea N, Hickey A, Quinn F. Comparing the outcomes of tubularized incised plate urethroplasty and dorsal inlay graft urethroplasty in children with hypospadias: a systematic review and meta-analysis. J Pediatr Urol. 2020 Apr;16(2):154-161. doi: 10.1016/j.jpurol.2020.01.009. Epub 2020 Jan 22.
- Background: PubMed 26455467Liu MM, Holland AJ, Cass DT. Assessment of postoperative outcomes of hypospadias repair with validated questionnaires. J Pediatr Surg. 2015 Dec;50(12):2071-4. doi: 10.1016/j.jpedsurg.2015.08.047. Epub 2015 Sep 1.
- Background: PubMed 25819601Pfistermuller KL, McArdle AJ, Cuckow PM. Meta-analysis of complication rates of the tubularized incised plate (TIP) repair. J Pediatr Urol. 2015 Apr;11(2):54-9. doi: 10.1016/j.jpurol.2014.12.006. Epub 2015 Feb 26.
- Background: PubMed 31155410Seleim HM, ElSheemy MS, Abdalazeem Y, Abdullateef KS, Arafa MA, Shouman AM, Elsaket H, Kaddah SN, Elbarbary MM. Comprehensive evaluation of grafting the preservable narrow plates with consideration of native plate width at primary hypospadias surgery. J Pediatr Urol. 2019 Aug;15(4):345.e1-345.e7. doi: 10.1016/j.jpurol.2019.05.002. Epub 2019 May 9.
- Background: PubMed 26119452Ahmed M, Alsaid A. Is combined inner preputial inlay graft with tubularized incised plate in hypospadias repair worth doing? J Pediatr Urol. 2015 Aug;11(4):229.e1-4. doi: 10.1016/j.jpurol.2015.05.015. Epub 2015 Jun 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair surgery in people with Penile Hypospadias, run by Assiut University at 1 site in Egypt.
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 5 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 6 Sep 2022. 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 Egypt. 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.
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 abdelrahman M abdelkader (01068336396 ext. 0882042046, abdelrahmanmohamed.aa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time. (time frame: intraoperative). The study lists 3 primary outcomes in all. 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 NCT05528276, 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 6 Sep 2022.