Actively Recruiting

Phase Not Applicable
Age: 6Months - 120Months
MALE
ID07086963

Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial

Led by Mohammad Daboos · Updated on 2025-07-25

584

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating surgical techniques for boys with primary hypospadias without chordee to see if adding a grafted inlay patch to the standard Tubularized Incised Plate (TIP) repair improves outcomes. The study compares the functional and cosmetic results of the two methods and examines complications like fistulas, wound issues, and the need for additional surgeries. Participants are randomly assigned to one of two surgery groups: Group 1 receives the standard TIP repair as described by Snodgrass, while Group 2 undergoes TIP repair combined with a grafted inlay patch using a preputial graft. Both surgeries involve urethroplasty performed over a catheter, spongioplasty, and careful skin closure to reduce complications. The study visits include postoperative checks around day 5, catheter removal in the second week, and regular follow-ups with urethral calibration monthly for six months. During the six-month follow-up, researchers assess surgical success by examining the position and shape of the urethral opening, the function of the new urethra, cosmetic appearance, and any complications. Scoring systems are used to evaluate outcomes after six months, and patients are closely monitored for healing and any need for further surgery. The total participation includes routine clinical visits and assessments to ensure detailed tracking of the surgical results.

CONDITIONS

Brief Title

Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?

Who Can Participate

Age: 6Months - 120Months
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary hypospadias candidates for one-stage repair
  • Uncircumcised cases
  • Pediatric age group
  • Patients with regular follow up
Not Eligible

You will not qualify if you...

  • Presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair
  • Small glans less than 11mm
  • Glanular hypospadias

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - 5 days

Participants undergo one of two types of surgical repair for primary hypospadias, either standard TIP repair or TIP with a grafted inlay patch. Immediate post-operative care includes monitoring until initial healing.

1 visit on the 5th postoperative day (in-person)

Post-operative Follow-up

Duration - 6 months

Participants return for catheter removal after complete healing, calibration visits to assess urethral function, and monthly follow-up visits to monitor healing and functional outcomes.

1 visit at 2 weeks for catheter removal, 1 visit one week after catheter removal, then monthly visits for 6 months

Trial Site Locations

Total: 1 location

1

Mohammad Daboos

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mohammad Daboos, Prof

M

Mohammad Negm, Prof

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Is dorsal inlay graft (DIG) with TIP repair superior to TIP alone for primary hypospadias? A randomized clinical trial.

Mohamed Ahmed Negm, Ahmed Abdelmoneim Abdelrasheed, Mohammad Daboos...

https://pubmed.ncbi.nlm.nih.gov/41588344