Concealed Penis in Pediatric Age Group

NCT05565040 — Not applicable, Completed, 150 participants, Egyptian Biomedical Research Network

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT05565040
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment150 (Actual)
SponsorEgyptian Biomedical Research Network (Network)
ConditionsPediatric ALL, Surgery, Urologic Diseases
InterventionsCircumcision in concealed penis (Procedure)
Datesstart 2018-06-01, primary completion 2021-06-01, completion 2021-06-01, first posted 2022-10-04, last updated 2022-10-07
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Pediatric ALL All trials for Surgery All trials of Circumcision in concealed penis

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Phallopexy groupExperimentalProcedure: Circumcision in concealed penisphallopexy only
Dartos excision groupExperimentalProcedure: Circumcision in concealed peniscomplete circumferential dissection and excision of dartos fascia only
Combined phallopexy and dartos excision groupExperimentalProcedure: Circumcision in concealed penisphallopexy as in patients of group A but after complete dissection and excision of dartos fascia
  • Circumcision in concealed penis (Procedure): comparison of three surgical techniques (as described in the arms) in the management of concealed penis in pediatrics

+Outcome measures

Primary outcomes

  • 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
  • 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
  • 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
  • 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

Sex: Male

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.

+Locations (1)

FacilityCityCountryStatus
Faulty of MedicineAlexandriaEgypt

+Publications

  • Results publication: 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

+Study documents

+Investigators