NCT07615439

Brief Summary

A concealed penis (CP) refers to a condition in which the normally-sized penis appears smaller or completely hidden in the prepubic area. Surgical repair of pediatric concealed penis is generally safe and efficacious. Criteria for pediatric concealed penis surgical success are still poorly standardized, so our study presents a multi-dimensional framework consisting of objective morphometric measurement (CI) and subjective psychometric tools (BP Questionnaire and MPPPS) for comprehensive evaluation of long-term anatomical, functional and aesthetic outcomes following the repair.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 19, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

deglovingsatisfactionconcealed

Outcome Measures

Primary Outcomes (1)

  • The immediate postoperative period

    number of participants with postoperative penile skin edema

    1-2 weeks

Secondary Outcomes (1)

  • The longterm postoperative results

    1 year

Interventions

Under GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked wit

Eligibility Criteria

Age1 Year - 12 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsconcealed penis is a morbidity that happens to males only
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis

You may qualify if:

  • children diagnosed with concealed penis, age ranged from 1 to 12 years

You may not qualify if:

  • children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar Afandy

Kafr ash Shaykh, 33516, Egypt

Location

MeSH Terms

Conditions

Degloving InjuriesPersonal Satisfaction

Condition Hierarchy (Ancestors)

Soft Tissue InjuriesWounds and InjuriesBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 29, 2026

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations