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NCT Number: NCT05565040

Concealed Penis in Pediatric Age Group

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.

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Key information

Conditions

Pediatric ALL Degloving Injuries Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Soft Tissue Injuries Surgery Urogenital Diseases Urologic Diseases Wounds and Injuries

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faulty of Medicine

Alexandria, 12345, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Circumcision in concealed penis

Procedure

comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics

Primary outcomes

  1. Post-operative appearance of penile skin congestion and/or necrosis

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 4, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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