Back to resultsZ-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
Primary Purpose
Urologic Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Z-scrotoplasty
Heineke-Mikulicz scrotoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Urologic Diseases focused on measuring Penoscrotal web, Z-scrotoplasty, Heineke-Mikulicz
Eligibility Criteria
Inclusion Criteria: Patients with congenital penoscrotal web in the pediatric age group Exclusion Criteria: Patients with any penile anomalies
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Z-scrotoplasty
Heineke-Mikulicz scrotoplasty
Arm Description
Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty
Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty
Outcomes
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
Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing
Secondary Outcome Measures
Full Information
NCT ID
NCT05817760
First Posted
March 19, 2023
Last Updated
April 5, 2023
Sponsor
Egyptian Biomedical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT05817760
Brief Title
Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
Official Title
Evaluation of Z-plasty Versus Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web in Pediatric Age Group
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Egyptian Biomedical Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
Penoscrotal web, Z-scrotoplasty, Heineke-Mikulicz
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Z-scrotoplasty
Arm Type
Experimental
Arm Description
Pediatric patients with congenital penoscrotal web who will be treated by Z-scrotoplasty
Arm Title
Heineke-Mikulicz scrotoplasty
Arm Type
Experimental
Arm Description
Pediatric patients with congenital penoscrotal web who will be treated by Heineke-Mikulicz scrotoplasty
Intervention Type
Procedure
Intervention Name(s)
Z-scrotoplasty
Intervention Description
Z shape incision of the penoscrotal web and closure
Intervention Type
Procedure
Intervention Name(s)
Heineke-Mikulicz scrotoplasty
Intervention Description
Transverse incision of the penoscrotal web with vertical closure
Primary Outcome Measure Information:
Title
Number of patients who developed post-operative penile edema, hematoma, adequate skin coverage and wound contracture with recurrent webbing will be assessed
Description
Post-operative follow up for the detection of penile edema, hematoma, skin coverage and the development of any wound contracture and consequently recurrent webbing
Time Frame
One post-operative year
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with congenital penoscrotal web in the pediatric age group
Exclusion Criteria:
Patients with any penile anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Elrouby, MD
Organizational Affiliation
Pediatric Surgery department
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine
City
Alexandria
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Z-plasty and Heineke-Mikulicz Scrotoplasty in the Management of Penoscrotal Web
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