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Clinical Trials/NCT05528276
NCT05528276Not yet recruitingNot Applicable

Does Preputial Inlay Graft Improves the Outcome of Tubularized Incised Plate Repair for Primary Distal Hypospadias? a Prospective Randomized Controlled Trial.

Assiut University2 sites in 1 country25 target enrollmentStarted: August 29, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
25
Locations
2
Primary Endpoint
Operation time.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to 12 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Operation time.

Time Frame: intraoperative

the duration of the operation will be measured from the start of anesthesia to end.

site of the meatus

Time Frame: 6 months from the operation

the meatal position will be measured in centimeters from the original position .

blood loss.

Time Frame: one hour postoperatively

the amount of blood loss will be measured by CBC

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdelrahman Mohamed Abdelkader

teaching assistant of urology & andrology

Assiut University

Study Sites (2)

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