Concealed Penis in Pediatric Age Group

NCT05565040 | Completed

• 1 other identifier: 0305434
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL; Surgery; Urologic Diseases

Keywords

Concealed; phallopexy; dartos excision; degloving; penile re-retraction

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Phallopexy group

EXPERIMENTAL

phallopexy only

Procedure: Circumcision in concealed penis

Dartos excision group

EXPERIMENTAL

complete circumferential dissection and excision of dartos fascia only

Procedure: Circumcision in concealed penis

Combined phallopexy and dartos excision group

EXPERIMENTAL

phallopexy as in patients of group A but after complete dissection and excision of dartos fascia

Procedure: Circumcision in concealed penis

Interventions

Circumcision in concealed penis PROCEDURE

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

Combined phallopexy and dartos excision group; Dartos excision group; Phallopexy group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Faulty of Medicine

Alexandria, 12345, Egypt

Location

Related Publications (1)

• Elrouby A. Concealed penis in pediatric age group: a comparison between three surgical techniques. BMC Urol. 2023 Jan 11;23(1):9. doi: 10.1186/s12894-022-01169-3.

  PMID: 36631822 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Urologic Diseases; Degloving Injuries

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Soft Tissue Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ahmed EZ Elrouby, A.Professor

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Surgery, Alexandria University

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 4, 2022
• Study Start: June 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)