NCT05660564

Brief Summary

Introduction: Hypospadias repair is debated. There has been no perfect procedure until this moment. A graft is sometimes needed to fundamentally strengthen the narrow urethral plate. Patients and methods: The study included a child who had primary distal or mid-penile hypospadias at the age of 6 months or more, a urethral plate less than 8 mm in a non-circumcised penis, and was operated on using the Snodgraft technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

Same day

First QC Date

December 13, 2022

Last Update Submit

December 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 75% success rate

    one and half year

Interventions

Using a scalpel, a midline incision is made from the meatus to the end of the plate . The edge of the distal glans should not be incised to avoid meatal stenosis. The depth of this relaxing incision depends on the plate's width and depth, but in all cases, it extends down to the corpora cavernosa. Degloving of the penile skin to the penoscrotal junction If a minimal chord is present, it should be corrected. From the inner prepuce, a free graft was measured, harvested, defatted, and stitched to the UP. With interrupted 6/0 polyglactin sutures running from the old meatus to the tip of the glans, the graft was secured to the medial edges of the incised plate. Depending on the location of the meatus, the characteristics of the UP, and the depth of the midline incision, the graft width and length varied in each case.

Eligibility Criteria

Age6 Months - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study included hypospadias patients who were admitted to a hypospadias clinic at a university hospital.

You may not qualify if:

  • Children with redo hypospadias, significant Chordee (30 percent or more), non-preservable plates, circumcised patients, and proximal hypospadias were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Magdy Abdelmohsen

Cairo, 11331, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

May 1, 2018

Primary Completion

May 1, 2018

Study Completion

October 30, 2019

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations