Hybrid Duckett vs Modified Duckett Urethroplasty for Proximal Hypospadias

September 12, 2024 updated by: Mohammad Gharieb Mohammad Khirallah, Tanta University

Hybrid Duckett Urethroplasty Versus Modified Single Stage Duckett Uteothroplasty for Management of Proximal Hypospadias: a Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A hybrid Duckett urethroplasty
Procedure: Duckett urethroplasty
hybrid duckett urethroplasty vs modified duckett urethroplasty
Active Comparator: group B modified Duckett urethroplasty
Procedure: Duckett urethroplasty
hybrid duckett urethroplasty vs modified duckett urethroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
repair of proximal hypospadias without fistula
Time Frame: six months post operative
strong strait stream of urine, no fistula formation, no urethral stricture
six months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 17, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35171/12/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the preoperative photos, operative photos and postoperative photos will be sharable with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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