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

NCT07086963 | Recruiting

• 1 other identifier: SVU/SUR011/4/22/12/519
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypospadias

Keywords

Grafted TIP; Tabularized Incised Plate

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Repaired with standard Tubularized incised plate repair as described by Snodgrass

Procedure: Repaired with standard TIP repair as described by Snodgrass

Group 2

ACTIVE COMPARATOR

Repaired with Grafted Tubularized incised plate repair using preputial graft

Procedure: Repaired with TIP with GIP using preputial graft

Interventions

Repaired with standard TIP repair as described by Snodgrass PROCEDURE

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

Group 1

Repaired with TIP with GIP using preputial graft PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 6 Months - 120 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mohammad Daboos: lead

Study Sites (1)

Mohammad Daboos

Cairo, Egypt

RECRUITING

Related Publications (1)

• Negm MA, Abdelrasheed AA, Daboos M, Khedre MM, Abdelrahman MF, Abo-Halawa NAE, Ibrahim IA, Shehata MA. Is dorsal inlay graft (DIG) with TIP repair superior to TIP alone for primary hypospadias? A randomized clinical trial. BMC Pediatr. 2026 Jan 26. doi: 10.1186/s12887-025-06247-7. Online ahead of print.

  PMID: 41588344 DERIVED

MeSH Terms

Conditions

Hypospadias

Interventions

Lysine Acetyltransferase 5

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Histone Acetyltransferases; Lysine Acetyltransferases; Acetyltransferases; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Mohammad Daboos

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Daboos, Prof

CONTACT

01007578148; daboosmohammad@gmail.com

Mohammad Negm, Prof

CONTACT

01550087767; yww4178@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.

Model Details: Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 25, 2025
• Study Start: January 2, 2023
• Primary Completion: July 25, 2025
• Study Completion: August 8, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

EG (1)