Concealed Penis in Pediatric Age Group

Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia & group C; patients treated by both phallopexy and dartos excision.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases; Surgery; Pediatric ALL
• Intervention / Treatment: Procedure: Circumcision in concealed penis

Detailed Description

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 & 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia & group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 12345
    • Faulty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature

Exclusion Criteria:

• Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phallopexy group; phallopexy only	Procedure: Circumcision in concealed penis; comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics
Experimental: Dartos excision group; complete circumferential dissection and excision of dartos fascia only	Procedure: Circumcision in concealed penis; comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics
Experimental: Combined phallopexy and dartos excision group; phallopexy as in patients of group A but after complete dissection and excision of dartos fascia	Procedure: Circumcision in concealed penis; comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative appearance of penile skin congestion and/or necrosis	Repeated and regular monthly examination of the patients as regards persistent bluish penile discoloration and or loss of penile skin viability. Also a questionnaire of parents about penile skin color, loss of skin, and/or appearance of any abnormal tissues	6 months
Wound infection	Repeated and regular monthly examination of the patients as regards the appearance of any penile skin infection and/or pyogenic discharge. Also a questionnaire of parents about the appearance of penile skin redness, pyogenic discharge, and/or the appearance of any pyogenic membranes	6 months
Penile edema	Repeated and regular monthly examination of the patients as regards the appearance of penile skin edema. Also a questionnaire of parents about any increase of penile girth than the usual	6 months
Penile re-retraction	Repeated and regular monthly examination of the patients as regards the development of any penile re-retraction in the form of retraction of the penis to or beneath the level of pubic skin. Also, a questionnaire of parents about this finding was done	6 months

Collaborators and Investigators

• Sponsor: Egyptian Biomedical Research Network
• Investigators: Principal Investigator: Ahmed EZ Elrouby, A.Professor, University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Concealed; phallopexy; dartos excision; degloving; penile re-retraction
• Additional Relevant MeSH Terms: Urologic Diseases
• Other Study ID Numbers: 0305434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No