Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Penile Hypospadias
• Intervention / Treatment: Procedure: Repair surgery

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: abdelrahman M abdelkader; Phone Number: 0882042046 01068336396; Email: abdelrahmanmohamed.aa@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospital
    • Contact: abdelrahman M abdelkader; Phone Number: 01068336396; Email: abdelrahmanmohamed.aa@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard Tubularized incised plate urethroplasty (sTIPU)	Procedure: Repair 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.
Active Comparator: Preputial inlay graft urethroplasty (PIGU)	Procedure: Repair 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time.	the duration of the operation will be measured from the start of anesthesia to end.	intraoperative
blood loss.	the amount of blood loss will be measured by CBC	one hour postoperatively
site of the meatus	the meatal position will be measured in centimeters from the original position .	6 months from the operation

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 29, 2022
• Primary Completion (Anticipated): October 29, 2024
• Study Completion (Anticipated): October 29, 2024

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: hypospadias repair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No