Concealed Penis in Pediatric Age Group

NCT ID: NCT05565040

Last Updated: 2022-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric ALL Surgery Urologic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phallopexy group

phallopexy only

Group Type EXPERIMENTAL

Circumcision in concealed penis

Intervention Type PROCEDURE

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

Dartos excision group

complete circumferential dissection and excision of dartos fascia only

Group Type EXPERIMENTAL

Circumcision in concealed penis

Intervention Type 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

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

Group Type EXPERIMENTAL

Circumcision in concealed penis

Intervention Type PROCEDURE

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

Interventions

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Circumcision in concealed penis

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Ahmed Elrouby

Associate Professor of Pediatric Surgery, Alexandria University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed EZ Elrouby, A.Professor

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Faulty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 36631822 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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0305434

Identifier Type: -

Identifier Source: org_study_id

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