Concealed Penis in Pediatric Age Group
Primary Purpose
Pediatric ALL, Surgery, Urologic Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Circumcision in concealed penis
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric ALL focused on measuring Concealed, phallopexy, dartos excision, degloving, penile re-retraction
Eligibility Criteria
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.
Sites / Locations
- Faulty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Phallopexy group
Dartos excision group
Combined phallopexy and dartos excision group
Arm Description
phallopexy only
complete circumferential dissection and excision of dartos fascia only
phallopexy as in patients of group A but after complete dissection and excision of dartos fascia
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05565040
First Posted
September 21, 2022
Last Updated
October 5, 2022
Sponsor
Egyptian Biomedical Research Network
1. Study Identification
Unique Protocol Identification Number
NCT05565040
Brief Title
Concealed Penis in Pediatric Age Group
Official Title
Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL, Surgery, Urologic Diseases
Keywords
Concealed, phallopexy, dartos excision, degloving, penile re-retraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phallopexy group
Arm Type
Experimental
Arm Description
phallopexy only
Arm Title
Dartos excision group
Arm Type
Experimental
Arm Description
complete circumferential dissection and excision of dartos fascia only
Arm Title
Combined phallopexy and dartos excision group
Arm Type
Experimental
Arm Description
phallopexy as in patients of group A but after complete dissection and excision of dartos fascia
Intervention Type
Procedure
Intervention Name(s)
Circumcision in concealed penis
Intervention Description
comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics
Primary Outcome Measure Information:
Title
Post-operative appearance of penile skin congestion and/or necrosis
Description
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
Time Frame
6 months
Title
Wound infection
Description
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
Time Frame
6 months
Title
Penile edema
Description
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
Time Frame
6 months
Title
Penile re-retraction
Description
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
Time Frame
6 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed EZ Elrouby, A.Professor
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faulty of Medicine
City
Alexandria
ZIP/Postal Code
12345
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Concealed Penis in Pediatric Age Group
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