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

NCT05528276 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-09-06

No results posted yet for this study

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

Interventions

PROCEDURE

Repair surgery

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-29
Primary Completion
2024-10-29
Completion
2024-10-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05528276 on ClinicalTrials.gov