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

Primary Purpose

Penile Hypospadias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repair surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Penile Hypospadias

Eligibility Criteria

1 Year - 12 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard Tubularized incised plate urethroplasty (sTIPU)

Preputial inlay graft urethroplasty (PIGU)

Arm Description

Outcomes

Primary Outcome Measures

Operation time.
the duration of the operation will be measured from the start of anesthesia to end.
blood loss.
the amount of blood loss will be measured by CBC
site of the meatus
the meatal position will be measured in centimeters from the original position .

Secondary Outcome Measures

Full Information

First Posted
August 28, 2022
Last Updated
September 2, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05528276
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 29, 2022 (Anticipated)
Primary Completion Date
October 29, 2024 (Anticipated)
Study Completion Date
October 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Hypospadias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard Tubularized incised plate urethroplasty (sTIPU)
Arm Type
Active Comparator
Arm Title
Preputial inlay graft urethroplasty (PIGU)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Repair surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Operation time.
Description
the duration of the operation will be measured from the start of anesthesia to end.
Time Frame
intraoperative
Title
blood loss.
Description
the amount of blood loss will be measured by CBC
Time Frame
one hour postoperatively
Title
site of the meatus
Description
the meatal position will be measured in centimeters from the original position .
Time Frame
6 months from the operation

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children age more than 12 months to 12 years. De-novo penile hypospadias after degloving of penis intraoperative (fresh, not previously operated) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
abdelrahman M abdelkader
Phone
01068336396
Ext
0882042046
Email
abdelrahmanmohamed.aa@gmail.com
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
abdelrahman M abdelkader
Phone
01068336396
Email
abdelrahmanmohamed.aa@aun.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32061491
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.
Results Reference
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PubMed Identifier
26455467
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.
Results Reference
background
PubMed Identifier
25819601
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.
Results Reference
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PubMed Identifier
31155410
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.
Results Reference
background
PubMed Identifier
26119452
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.
Results Reference
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Does Graft Improves the Outcome TIP Repair for Primary Distal Hypospadias?

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