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

ConditionHypospadias
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6-120
SponsorMohammad Daboos

About this trial

This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.

the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary hypospadias candidates for one-stage repair

Uncircumcised cases

Pediatric age group

Patients with regular follow up

Disqualifiers

The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair

Small glans < 11mm

glanular hypospadias

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repaired with standard TIP repair as described by Snodgrass

    Procedure/Surgery

    Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF

  • Repaired with TIP with GIP using preputial graft

    Procedure/Surgery

    The urethral plate was deeply incised from the glans tip, extending downwards beyond the junction between the plate and the hypospadiac meatus Graft fixation The graft was then spread to cover the raw area and fixed to the edges of the urethral plate. Urethroplasty was performed over a 6-8 Fr Nelaton catheter (according to patient age and glans size) using 7/0 subcuticular continuous suture. Adequate meatus was left around the urethral catheter at the glans tip, followed by spongioplasty and a second-layer dartos fascia coverage. Mucosal collar approximation and skin closure Glanular closure was then initiated with deep but superficial stitches using 7/0 or 6/0 polyglactin suture, and mucosal suture closure. Skin closure was achieved by preparing viable skin while avoiding midline skin closure by preparing a vascularized preputial skin flap to avoid skin coverage complications with subsequent UCF

Treatment groups

584 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical outcomes

complications rates

Time frame
6 months
2

cosmetic results

cosmetic results with Hypospadias Objective Scoring Evaluation.

Time frame
6 months
3

Functional outcomes

Urine Flow from the neourethra

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohammad Daboos

Lead sponsor

Al-Azhar University

Sponsor institution

Source ClinicalTrials.gov
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