Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias

NCT ID: NCT06598215

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-08-01

Brief Summary

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proximal hypospadias presents a serious anomaly for both infants and their care givers. a variety of techniques were described through decades. None of them is completely curable. hundred of modifications were adopted to the original techniques. during the current study, we will do hybrid Duckett urethroplasty which is a staged procedure and compare it to modified Duckett urethroplasty which is a single stage procedure.

Detailed Description

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two groups of infants diagnosed with proximal hypospadias will be allocated in two groups. group A will include cases of who will be operated upon using hybrid Duckett urethroplasty. group B will include patients who will be operated upon using modified duckett urethroplasty.

recruitment in either group will be done using sealed envelop method. in group A patient will have a double face Duckett tube which will be transferred to the ventral of the penis. the tube will be secured in place however, no proximal anastomosis with the meatus. the anastomosis will be scheduled six months later. In group B patients a double face Duckett tube will be transferred to the ventral aspect of the penis with completion of the anastomosis with the proximal meatus at the same session. the primary out come will be completion of the procedure and restoration of the urethral continuity. secondary out come will the cosmetic appearance

Conditions

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Proximal Hypospadias Modified Duckett Urethroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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group A hybrid Duckett urethroplasty

Group Type ACTIVE_COMPARATOR

Duckett urethroplasty

Intervention Type PROCEDURE

hybrid duckett urethroplasty vs modified duckett urethroplasty

group B modified Duckett urethroplasty

Group Type ACTIVE_COMPARATOR

Duckett urethroplasty

Intervention Type PROCEDURE

hybrid duckett urethroplasty vs modified duckett urethroplasty

Interventions

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Duckett urethroplasty

hybrid duckett urethroplasty vs modified duckett urethroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* all infants and children with proximal hypospadias

Exclusion Criteria

* disorders of sex developments
* previous penile surgery
* circumcised children
* crippled penis
* refusal of the plan of the management by the care givers
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Gharieb Mohammad Khirallah

professor of pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospitals

Tanta, Elgharbeya, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohammad khirallah, professor

Role: CONTACT

00201118420783

Nagi Eldessouki, professor

Role: CONTACT

00201010477452

Facility Contacts

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suzan Ezzat, professor

Role: primary

00201010477452

Nagi Eldessouki, professor

Role: backup

00201227465887

Other Identifiers

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35171/12/21

Identifier Type: -

Identifier Source: org_study_id

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