## Protocol Section
### Identification Module
**NCT ID:** NCT06413901

**Brief Title:** TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures

**Official Title:** TIP Repair of Distal Penile Hypospadias Using Rapidly Absorbable Braided Vs Slowly Absorbable Monofilament Sutures: A Prospective, Randomized Controlled Study

#### Organization Study ID Info
**ID:** N-421-2023
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-05
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mohamed Abdelghany

**Investigator Title:** lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Objective:

To study the effect of tubularizing the urethral plate in DPH in children using 2 different absorbable suture materials, rapidly absorbable, braided 6/0 Vicryl and slowly absorbable monofilament 6/0 Polydioxanone, on complication rates.

Patients and methods:

A prospective, randomized controlled study conducted at the Urology Department, Cairo University Specialized Pediatric Hospital, Abou El Reesh, between September 2021 and September 2022. A total of 69 boys aged between 8 and 120 months with DPH were randomly divided into 2 groups: group(A) Vicryl included 39 boys and group(B) PDS included 30 boys. All boys were uncircumcised with no chordee and were primary repairs. TIP was the surgical technique used by a single pediatric urologist. Follow up was performed in outpatient clinic at 7 days, 1, 3, 6 and 12 months postoperatively. The complications and reoperation rates for both groups were compared.

### Conditions Module

**Conditions:**

- Hypospadias Repair

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 69

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TIP hypospadias repair

**Intervention Names:**

- Procedure: TIP

**Label:** Vicryl group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** TIP hypospadias repair

**Intervention Names:**

- Procedure: TIP

**Label:** PDS group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PDS group

- Vicryl group

**Description:** TIP hypospadias repair

**Name:** TIP

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** urethrocutaneous fistula, wound infection, wound dehiscence, overall complications, and reoperation rates

**Measure:** complication rate

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Any child(aged from 6m to 12 years old) with distal penile hypospadias (DPH) ( uncircumcised, without chordae, with good penile size and urethral plate(candidates for T.I.P repair)

Exclusion Criteria:

* reccurent cases,
* circumcised cases
* other types of hypospadias rather than DPH,
* presence of chordae,
* poor urethral plate

**Maximum Age:** 12 Years

**Minimum Age:** 6 Months

**Sex:** MALE

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Cairo University

**Zip:** 02

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014564

- Term: Urogenital Abnormalities

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000010409

- Term: Penile Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10071

- Name: Hypospadias

- Relevance: HIGH

- As Found: Hypospadias

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M17314

- Name: Urogenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M13320

- Name: Penile Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007021

- Term: Hypospadias

### Misc Info Module

- Version Holder: 2024-05-31
