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

Mohammad Daboos

Status: Enrolling

Conditions: Hypospadias

Treatments: Procedure: Repaired with TIP with GIP using preputial graft; Procedure: Repaired with standard TIP repair as described by Snodgrass

Study type: Interventional

Funder types: Other

Identifiers

NCT07086963

SVU/SUR011/4/22/12/519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 584 estimated patients

Sex: Male

Ages: 6 to 120 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

584 participants in 2 patient groups

Group 1

Active Comparator group

Description:

Repaired with standard Tubularized incised plate repair as described by Snodgrass

Treatment:

Procedure: Repaired with standard TIP repair as described by Snodgrass

Group 2

Active Comparator group

Description:

Repaired with Grafted Tubularized incised plate repair using preputial graft

Treatment:

Procedure: Repaired with TIP with GIP using preputial graft