Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web

Sponsor

Egyptian Biomedical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT05817760

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases	Procedure: Z-scrotoplasty Procedure: Heineke-Mikulicz scrotoplasty	N/A

Detailed Description

Background: The penoscrotal web may be congenital or acquired after excessive removal of ventral skin during circumcision. There are several previously described surgical techniques for the treatment of congenital webbed penis without a clear comparison between their outcomes. Purpose: the objective of our study was to compare the surgical results of Z-scrotoplasty and Heineke-Mikulicz scrotoplasty in the treatment of congenital webbed penis. Patients & Methods: Our prospective study included 40 uncircumcised patients presented with a webbed penis. They were divided into group A which was treated by Z-scrotoplasty and group B which was treated by Heineke-Mikulicz scrotoplasty.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Z-scrotoplasty Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty	Procedure: Z-scrotoplasty Z shape incision of the penoscrotal web and closure
Experimental: Heineke-Mikulicz scrotoplasty Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty	Procedure: Heineke-Mikulicz scrotoplasty Transverse incision of the penoscrotal web with vertical closure

Arm

Intervention/Treatment

Experimental: Z-scrotoplasty

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

Procedure: Z-scrotoplasty

Z shape incision of the penoscrotal web and closure

Experimental: Heineke-Mikulicz scrotoplasty

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

Procedure: Heineke-Mikulicz scrotoplasty

Transverse incision of the penoscrotal web with vertical closure

Outcome Measures

Primary Outcome Measures

Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed [One post-operative year]
Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with congenital penoscrotal web in the pediatric age group

Exclusion Criteria:

Patients with any penile anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Alexandria		Egypt	12345

Sponsors and Collaborators

Egyptian Biomedical Research Network

Investigators

Study Director: Ahmed Elrouby, MD, Pediatric Surgery department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Elrouby, Associate Professor of pediatric Surgery, Egyptian Biomedical Research Network

ClinicalTrials.gov Identifier:

NCT05817760

Other Study ID Numbers:

0305354

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Elrouby, Associate Professor of pediatric Surgery, Egyptian Biomedical Research Network

Penoscrotal web

Z-scrotoplasty

Heineke-Mikulicz

Additional relevant MeSH terms:

Urologic Diseases

Study Results

No Results Posted as of Apr 18, 2023