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

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

Study Overview

• Status: Recruiting
• Conditions: Hypospadias
• Intervention / Treatment: Procedure: Repaired with standard TIP repair as described by Snodgrass; Procedure: Repaired with TIP with GIP using preputial graft

Detailed Description

This prospective, randomized study included all patients who presented with primary hypospadias without chordee.

investigators aimed to investigate whether grafted inlay patch with Tabularized Incised Plate 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.

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. Patients were randomized into two groups using sealed envelopes labeled as group 1 or group 2, selected by the operating theater chief nurse. An independent statistician approved the sample size.

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 first visit occurred on the 5th postoperative day. On 2nd week, the patients attended for catheter removal after complete healing. Calibration was performed one week after catheter removal, followed by monthly for the first six months, with HOSE scoring conducted after six months.

• Study Type: Interventional
• Enrollment (Estimated): 584
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Daboos, Prof; Phone Number: 01007578148; Email: daboosmohammad@gmail.com
• Study Contact Backup: Name: Mohammad Negm, Prof; Phone Number: 01550087767; Email: yww4178@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Mohammad Daboos
    • Contact: Mohammad Daboos; Phone Number: 01007578148; Email: daboosmohammad@gmail.com
    • Contact: Email: daboosmohammad@gmail.com
    • Principal Investigator: Mohammad Daboos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary hypospadias candidates for one-stage repair
• Uncircumcised cases
• Pediatric age group
• Patients with regular follow up

Exclusion Criteria:

• The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair
• Small glans < 11mm
• glanular hypospadias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Repaired with standard Tubularized incised plate repair as described by Snodgrass	Procedure: Repaired with standard TIP repair as described by Snodgrass; 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
Active Comparator: Group 2; Repaired with Grafted Tubularized incised plate repair using preputial graft	Procedure: Repaired with TIP with GIP using preputial graft; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical outcomes	complications rates	6 months
cosmetic results	cosmetic results with Hypospadias Objective Scoring Evaluation.	6 months
Functional outcomes	Urine Flow from the neourethra	6 months

Collaborators and Investigators

• Sponsor: Mohammad Daboos
• Investigators: Principal Investigator: Mohammad Daboos, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): July 25, 2025
• Study Completion (Estimated): August 8, 2025

Study Registration Dates

• First Submitted: July 5, 2025
• First Submitted That Met QC Criteria: July 17, 2025
• First Posted (Actual): July 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Grafted TIP; Tabularized Incised Plate
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Urogenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: SVU/SUR011/4/22/12/519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No