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OpenTrials
Completed

NCT Number: NCT04636476

One Stage Correction of Congenital Penile Curvature Complex

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

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Key information

Age range

2 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed M Shahin

Cairo, 34517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Clockwise rotation

    Time frame: 5 years

    Clockwise rotation of the penis (number & percent)

  2. Counterlockwise rotation

    Time frame: 5 years

    Counterlockwise rotation of the penis (number & percent)

  3. Ventral Curvature

    Time frame: 5 years

    Ventral Curvature of the penis (number & percent)

  4. Dorsal Curvature

    Time frame: 5 years

    Dorsal Curvature of the penis (number & percent)

  5. Lateral Curvature

    Time frame: 5 years

    Lateral Curvature of the penis (number & percent)

  6. Age

    Time frame: 5 years

    Age of the patients (years)

  7. Operative time

    Time frame: 1 day (day of surgery)

    Operative time (minutes)

  8. Post-operative hospital stay

    Time frame: 1 week

    Hospital stay period (days)

  9. Post-operative follow-up period

    Time frame: 5 years

    Follow-up period (months)

Secondary outcomes

  1. Functional impairment

    Time frame: 5 years

    Functional impairment (number & percent)

  2. Aesthetic impairment

    Time frame: 5 years

    Aesthetic impairment (number & percent)

  3. Residual curvature > 10°

    Time frame: 5 years

    Residual curvature > 10° (number & percent)

  4. Residual rotation > 10°

    Time frame: 5 years

    Residual rotation > 10° (number & percent)

  5. Post-operative paresthesia

    Time frame: 5 years

    Post-operative paresthesia (number & percent)

  6. Skin ischemia

    Time frame: 5 years

    Skin ischemia (number & percent)

  7. Hematoma

    Time frame: 5 years

    Hematoma (number & percent)

  8. Dressing soaked with blood

    Time frame: 5 years

    Dressing soaked with blood (number & percent)

Sponsors and collaborators

Lead sponsor

dr. Muhammad Abdelhafez Mahmoud, MD

Other

Registry information

Acronym: Al-AzharCPCC

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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