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/41588344Actively Recruiting
Led by Mohammad Daboos · Updated on 2025-07-25
584
Participants Needed
1
Research Sites
2 weeks
Total Duration
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
Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias?
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
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
Total: 1 location
1
Mohammad Daboos
Cairo, Egypt
Actively Recruiting
M
Mohammad Daboos, Prof
M
Mohammad Negm, Prof
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mohamed Ahmed Negm, Ahmed Abdelmoneim Abdelrasheed, Mohammad Daboos...
https://pubmed.ncbi.nlm.nih.gov/41588344