One Stage Correction of Congenital Penile Curvature Complex

NCT04636476 | Completed

• 1 other identifier: Al-AzharCPCC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To present update \& experience in management of congenital penile curvature complex.

Conditions

Congenital Anomaly; Chordee; Curvature of Penis; Torsion of the Penis

Keywords

Congenital penile curvature;; Penile rotation;; Dorsal dartos flap;; Complex anomaly

Outcome Measures

Primary Outcomes (9)

• Clockwise rotation

  Clockwise rotation of the penis (number \& percent)

  5 years

• Counterlockwise rotation

  Counterlockwise rotation of the penis (number \& percent)

  5 years

• Ventral Curvature

  Ventral Curvature of the penis (number \& percent)

  5 years

• Dorsal Curvature

  Dorsal Curvature of the penis (number \& percent)

  5 years

• Lateral Curvature

  Lateral Curvature of the penis (number \& percent)

  5 years

• Age

  Age of the patients (years)

  5 years

• Operative time

  Operative time (minutes)

  1 day (day of surgery)

• Post-operative hospital stay

  Hospital stay period (days)

  1 week

• Post-operative follow-up period

  Follow-up period (months)

  5 years

Secondary Outcomes (8)

• Functional impairment

  5 years

• Aesthetic impairment

  5 years

• Residual curvature > 10°

  5 years

• Residual rotation > 10°

  5 years

• Post-operative paresthesia

  5 years

Study Arms (1)

Modified Nesbit technique followed by dorsal dartos flap

OTHER

Modified Nesbit technique to correct penile curvature followed by dorsal dartos flap to correct penile torsion

Procedure: Modified Nesbit's procedure and dorsal dartos flap

Interventions

Modified Nesbit's procedure and dorsal dartos flap PROCEDURE

Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion

Modified Nesbit technique followed by dorsal dartos flap

Eligibility Criteria

• Age: 2 Years - 10 Years
• Gender Eligibility Details: Male children from 2-10 years old with CPCC with normal urethral meatus
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 10 years old boys
• with congenital curvature complex of the penis
• with normally situated urethral meatus.
• The various degrees of penile curvature ranged between 30° - 90° associated with 30° - 90° penile rotation

You may not qualify if:

• Boys with CPCC with abnormal urethral meatus as hypospadias or epispadias, or
• with the range of angle degree of penile curvature less than 30° associated with less than 30° penile rotation or
• with acquired penile curvature or
• having an isolated lesion.

Sponsors & Collaborators

• dr. Muhammad Abdelhafez Mahmoud, MD: lead

Study Sites (1)

Mohamed M Shahin

Cairo, 34517, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohamed M Shahin, MD,PhD

  Al-Azhar New Damietta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of pediatric surgery, Al-Azhar university, Faculty of Medicine

Model Details: Sequential Assignment Prospective cohort study

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: January 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: May 1, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: from now indefinitely
• Access Criteria: after the article became accepted and available online.

Locations

EG (1)