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

NCT05528276 | Unknown

• 1 other identifier: hypospadias repair
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Hypospadias

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

standard Tubularized incised plate urethroplasty (sTIPU)

ACTIVE COMPARATOR

Procedure: Repair surgery

Preputial inlay graft urethroplasty (PIGU)

ACTIVE COMPARATOR

Procedure: Repair surgery

Interventions

Repair surgery PROCEDURE

1. 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.

Preputial inlay graft urethroplasty (PIGU); standard Tubularized incised plate urethroplasty (sTIPU)

Eligibility Criteria

• Age: 1 Year - 12 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

Related Publications (5)

• 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.

  PMID: 32061491 BACKGROUND

• 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.

  PMID: 26455467 BACKGROUND

• 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.

  PMID: 25819601 BACKGROUND

• 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.

  PMID: 31155410 BACKGROUND

• 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.

  PMID: 26119452 BACKGROUND

MeSH Terms

Conditions

Hypospadias

Interventions

Sutureless Surgical Procedures

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Wound Closure Techniques; Surgical Procedures, Operative

Central Study Contacts

abdelrahman M abdelkader

CONTACT

01068336396; abdelrahmanmohamed.aa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant of urology & andrology

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 6, 2022
• Study Start: August 29, 2022
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)