NCT05817760

Brief Summary

The goal of this clinical trial is to compare the surgical outcome of Z-scrotoplasty versus Heineke-Mikulicz scrotoplasty in the management of congenital penoscrotal web in pediatric age group. The main question\[s\] it aims to answer are: • Question 1: Is there a difference in the surgical outcome between using Z-scrotoplasty and Heinke Miculickz scrotoplasty in the management of congenital penoscrotal web?\] Participants will be divided into two groups; Group A treated by Z-scrotoplasty and Group B treated by Heineke Miculickz scrotoplasty.

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 not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

March 19, 2023

Last Update Submit

April 5, 2023

Conditions

Keywords

Penoscrotal webZ-scrotoplastyHeineke-Mikulicz

Outcome Measures

Primary Outcomes (1)

  • Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed

    Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing

    One post-operative year

Study Arms (2)

Z-scrotoplasty

EXPERIMENTAL

Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty

Procedure: Z-scrotoplasty

Heineke-Mikulicz scrotoplasty

EXPERIMENTAL

Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty

Procedure: Heineke-Mikulicz scrotoplasty

Interventions

Z shape incision of the penoscrotal web and closure

Z-scrotoplasty

Transverse incision of the penoscrotal web with vertical closure

Heineke-Mikulicz scrotoplasty

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with congenital penoscrotal web in the pediatric age group

You may not qualify if:

  • Patients with any penile anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 12345, Egypt

Location

Related Publications (1)

  • Elrouby A. Evaluation of Z-plasty versus Heineke-Mikulicz scrotoplasty in the management of penoscrotal web in pediatric age group. BMC Urol. 2024 Mar 22;24(1):66. doi: 10.1186/s12894-024-01450-7.

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed Elrouby, MD

    Pediatric Surgery department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of pediatric Surgery

Study Record Dates

First Submitted

March 19, 2023

First Posted

April 18, 2023

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations