CClinicalTrials.gg
CompletedNCT04636476Al-AzharCPCCUpdated Nov 19, 2020

One Stage Correction of Congenital Penile Curvature Complex

An interventional study of Modified Nesbit's procedure and dorsal dartos flap in Congenital Anomaly, Chordee and Curvature of Penis, sponsored by dr. Muhammad Abdelhafez Mahmoud, MD. Completed at 1 site in Egypt. Open to male participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by dr. Muhammad Abdelhafez Mahmoud, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
2 Years to 10 Years
Sex
Male
01

Study summary

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

Read the detailed description

Type of study: prospective study

Review of literature:

  • Different modalities of urethroplasty for correction of CPCC without hypospadias (Nesbit, modified Nesbit, dorsal dartos flap, combined plication-incision CPI, suture fixation to pubic bone).
  • Merits of modified Nesbit technique accompanied by dorsal dartos flap for one-stage correction of CPCC without hypospadias.

This is a prospective study conducted at pediatric surgery department, New Damietta \& Alhoussain Al-Azhar University Hospitals, from January 2015 to May 2020, on 56 male patients with isolated CPCC. All of them will undergo one-stage correction corporoplasty using modified Nesbit technique accompanied by dorsal dartos flap.

Institutes of the study:

A multicenter study at Pediatric Surgery Departments, Al-Azhar University hospitals at New Damietta \& Cairo. Number of cases: Fifty-six male patients. Time frame: period of 5.6 years.

Ethical Consideration:

The protocol will be discussed and approved for clinical study by the Ethical Research Committee at the principal investigator's hospital. The study protocol was approved by local research and ethics committee of Al-Azhar Faculty of Medicine; the study protocol was explained to all guardians and their informed consents were obtained for involvement in the study. Confidentiality and the right to withdraw from the study at any time were guaranteed.

Preoperative preparation:

Children with CPCC those fulfill inclusion criteria will undergo a nursing evaluation of functional health status and a preoperative evaluation by an anesthesiologist \& pediatrician. The angle of penile rotation will be measured on the photograph, using Millen Med DICOM viewer program for image analysis, based on the orientation of the urethral meatus relative to the vertical position.

Follow-up:

Patients will be followed-up at OPD.

Statistical Analysis:

Data will be summarized into continuous variables expressed as mean ± standard deviation and categorical variables expressed as frequency count and percentage (%), using appropriate software computer package. Fisher's exact test is used for comparison of frequency counts/percentage. A two-sided p-value \< 0.05 is considered statistically significant.

Discussion:

It will focus on one-stage correction of congenital penile curvature complex (CPCC) using modified Nesbit's procedure (to correct curvature) and dorsal dartos flap (to correct torsion). The results obtained from this study will be compared between both group and with those reported in the literature. Also, it will focus on results, complications, their management, and clinical evaluation by noticing urine stream direction. At the end, the investigators will conclude that this technique ensures correction of the complex penile anomaly with satisfactory results and nice cosmetic outcome.

02

Conditions studied

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

Keywords

  • Congenital penile curvature;
  • Penile rotation;
  • Dorsal dartos flap;
  • Complex anomaly
03

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 2 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Other
    Modified Nesbit technique followed by dorsal dartos flap

    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

  • ProcedureModified Nesbit's procedure and dorsal dartos flap

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

05

What researchers measure

Primary outcomes

  1. Clockwise rotation

    Clockwise rotation of the penis (number \& percent)

    Time frame: 5 years

  2. Counterlockwise rotation

    Counterlockwise rotation of the penis (number \& percent)

    Time frame: 5 years

  3. Ventral Curvature

    Ventral Curvature of the penis (number \& percent)

    Time frame: 5 years

  4. Dorsal Curvature

    Dorsal Curvature of the penis (number \& percent)

    Time frame: 5 years

  5. Lateral Curvature

    Lateral Curvature of the penis (number \& percent)

    Time frame: 5 years

  6. Age

    Age of the patients (years)

    Time frame: 5 years

  7. Operative time

    Operative time (minutes)

    Time frame: 1 day (day of surgery)

  8. Post-operative hospital stay

    Hospital stay period (days)

    Time frame: 1 week

  9. Post-operative follow-up period

    Follow-up period (months)

    Time frame: 5 years

Secondary outcomes

  1. Functional impairment

    Functional impairment (number \& percent)

    Time frame: 5 years

  2. Aesthetic impairment

    Aesthetic impairment (number \& percent)

    Time frame: 5 years

  3. Residual curvature > 10°

    Residual curvature \> 10° (number \& percent)

    Time frame: 5 years

  4. Residual rotation > 10°

    Residual rotation \> 10° (number \& percent)

    Time frame: 5 years

  5. Post-operative paresthesia

    Post-operative paresthesia (number \& percent)

    Time frame: 5 years

  6. Skin ischemia

    Skin ischemia (number \& percent)

    Time frame: 5 years

  7. Hematoma

    Hematoma (number \& percent)

    Time frame: 5 years

  8. Dressing soaked with blood

    Dressing soaked with blood (number \& percent)

    Time frame: 5 years

06

Study locations

1 site
  • Mohamed M Shahin
    Cairo, 34517, Egypt
07

References and documents

Individual participant data

Plan to share: Yes — Data will be available for other researchers including methodology, figures, tables, results, and philosophy of discussion and the value this study will add to the literature

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04636476
Lead sponsor
dr. Muhammad Abdelhafez Mahmoud, MD
Responsible party
dr. Muhammad Abdelhafez Mahmoud, MD (Lecturer of pediatric surgery, Al-Azhar university, Faculty of Medicine, Al-Azhar University) — Sponsor-investigator
First posted
Nov 19, 2020
Start date
Jan 2015
Primary completion
Nov 2019
Completion
May 2020
Last update
Nov 19, 2020

Study contacts

Mohamed M Shahin, MD,PhD
principal investigator · Al-Azhar New Damietta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion