Clinical trial NCT05528276: Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?
Official title: Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penile Hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 25
Sex: MALE
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

1. Children age more than 12 months to 12 years.
2. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated)

Exclusion Criteria:

1. Circumcised
2. Ventral Penile curvature ≥30° after penile degloving \& artificial erection, (requiring transection of urethral plate).
3. Uretheral plate less than 6mm
4. Megameatus intact prepuce
5. Albumin less than 3.5 g/dL

Primary outcomes:
measure: Operation time.
timeFrame: intraoperative
measure: blood loss.
timeFrame: one hour postoperatively
measure: site of the meatus
timeFrame: 6 months from the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
citation: 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.
citation: Liu 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.
citation: Pfistermuller 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.
citation: Seleim 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.
citation: Ahmed 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.