Concealed Penis in Pediatric Age Group

Sponsor
Egyptian Biomedical Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT05565040
Collaborator
(none)
150
1
3
36
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Circumcision in concealed penis
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-operative appearance of penile skin congestion and/or necrosis [6 months]

    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

  2. Wound infection [6 months]

    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

  3. Penile edema [6 months]

    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

  4. Penile re-retraction [6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Egyptian Biomedical Research Network

Investigators

  • Principal Investigator: Ahmed EZ Elrouby, A.Professor, University of Alexandria

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Ahmed Elrouby, Associate Professor of Pediatric Surgery, Alexandria University, Egyptian Biomedical Research Network
ClinicalTrials.gov Identifier:
NCT05565040
Other Study ID Numbers:
  • 0305434
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 7, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Elrouby, Associate Professor of Pediatric Surgery, Alexandria University, Egyptian Biomedical Research Network
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2022