Distal Hypospadias Repair Outcome

November 19, 2024 updated by: Armia Ezzat Thabet Azer

Preoperative Predictors of Distal Hypospadias Repair Outcome

Aim is : To define the preoperative parameters that may influence the results of distal hypospadias repair

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypospadias is a congenital deformity where the opening of the urethra (the meatus) is sited on the underside (ventral) part of the penis, anywhere from the glans to the perineum.

It occurs in 1 in 250 live male births. it is often associated with "hooded" foreskin and chordee (ventral curvature of the penis shaft).

Hypospadias can be classified according to the anatomical location of meatus:

Distal-anterior hypospadias (located on the glans or distal shaft of the penis and the most common type of hypospadias) Intermediate-middle (penile). Proximal-posterior (penoscrotal, scrotal, perineal).

Diagnosis includes a description of the local findings:

Position, shape and width of the orifice Presence of atretic urethra and division of corpus spongiosum Appearance of the preputial hood and scrotum Size of the penis Curvature of the penis on erection. Aim of hypospadias surgery :(2) Is to correct penile curvature,to form neo-urethera of an adequate size, to bring the neomeatus to the tip of glans, and offer satisfactory cosmetic results.

The ideal age at surgery for primary hypospadias repair is usually 6-18 months. The complication rate is about 10% in distal hypospadias repair.

Complications include:

  1. uretherocutaneous fistula.
  2. meatal stenosis.
  3. urethral stricture.
  4. Urethral diverticulum. After hypospadias repairs, long-term follow-up is necessary, up to adolescence, to detect urethral stricture, voiding dysfunction and recurrent penile curvature.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Armia Ezzat Thabet Azer, bachelor degree
  • Phone Number: +201096067142
  • Email: armia.ezzat@yahoo.com

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Faculty of Medicine Assiut University
      • Assiut, Egypt, 71111
        • Noha Elabody
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child with distal hypospadias, uncircumcised , without meatal stenosis and no previous surgery for hypospadias

Exclusion Criteria:

  • Any surgical manipulation includes circumcision or meatotomy. Patient refusal to be enrolled in the research. Patient lost follow up in the first six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: DPH repair outcome
Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): A. Preoperative preparation: All patients will be subjected to evaluation including: 1. Measurement of penile length and width (in cm). 2. The shape of glans. (clefted , incomplete ceft, flat) 3. Glans size is measured by cubic centimetres. 4. Presence or absence of chordee and its degree. 5. Urethral plate condition and it's length, width and surface area. 6. Condition of skin over the urethra. 7. Presence of penile torsion. All patients should undergo preoperative surgical fitness including; complete blood picture, prothrombin time, concentration and INR, ECG and renal function test. Prophylactic systemic antibiotics are given intraoperatively.
Procedure: Distal Penile Hypospadias (Disorder)

Three operations which are Tubularized incised plate urethroplasty (TIP), Mathieu and meatal advancement and glanuplasty (MAGPI).

A three experienced operators with number of operations done by each one more than one hundred operation in the last year.

The operators will be fixed for each surgical technique as follows:

  1. Doctor (A) for Matheiu. ( 35 operations)
  2. Doctor (M) for MAGPI. ( 35 operations)
  3. Doctor (S) for TIP ( 35 operations). Tubularized incised plate urethroplasty:(3,6) Indication: for distal penile hypospadias with or without penile curvature with any width of the uretheral plate and also for any type of distal hypospadias associated with curvature.

Key steps for this operation are as follows:

Glans retraction using stay suture 4-0 or 5-0 silk. Uretheral catheter pass through hypospadic meatus to bladder. Parallel longitudenal incision is done 1-2mm proximal to hypospadic meatus. A circumferential incision is made 2-3 mm below coronal sulcus dorsally

Other Names:
  • Distal Penile Hypospadias repair outcome

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional outcome of Distal Penile Hypospadias Repair
Time Frame: Six months postoperatively

Functional Outcome of Distal Hypospadias Repair. Outcome Measure Title: Post-void Residual Volume (PVR) Measured via Abdominal Ultrasound Description: Assessment of urinary function through post-void residual volume using ultrasound, reported in milliliters (mL).

Time Frame: six months postoperatively.
Six months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cosmetic outcome of Distal Penile Hypospadias Repair
Time Frame: Six months postoperatively

Cosmetic Outcome of Distal Hypospadias Repair. Outcome Measure Title: Aesthetic Evaluation Based on Photographic Documentation Description: Assessment of cosmetic outcomes using photographs taken on postoperative days 0 (immediately after surgery), 3, and 5-7 (during catheter removal), scored on a 5-point Likert scale (1 = poor, 5 = excellent).

Time Frame: Six months postoperatively.
Six months postoperatively
Complication Rate Following Distal Hypospadias Repair
Time Frame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.

Complication Rate Following Distal Hypospadias Repair. Outcome Measure Title: Frequency of Postoperative Complications

Description: Detection and quantification of specific complications, including:

Edema of the glans or penile skin. Hematoma. Infection. Wound dehiscence. Urethrocutaneous fistula. Meatal stenosis. Urethral stricture. Urethral diverticula. Data will be reported as the number and percentage of patients experiencing each complication.

Time Frame: Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
Weekly assessments during the first month and monthly assessments for the following five months postoperatively.
Patient-Reported Outcomes
Time Frame: Six months postoperatively

Patient-Reported Outcomes. Outcome Measure Title: Satisfaction Score as Reported by Patients or Caregivers Description: Patients or their relatives will report satisfaction with surgical outcomes on a Visual Analog Scale (VAS) ranging from 0 (not satisfied) to 10 (very satisfied).

Time Frame: Six months postoperatively.
Six months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Armia Ezzat Thabet Azer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1) Belman AB. Hypospadias and chordee. In: Belman AB, King LR, Kramer SA, eds. Clinical Pediatric Urology. 4th edn. London, Martin Dunitz, 2002, pp. 1061-1092. 2) Mouriquand OD, Mure PY. Hypospadias. In: Gearhart J, Rink R, Mouriquand PDE, eds. Pediatric Urology, Philadelphia, WB Saunders, 2001, pp. 713-728. 3) Snodgrass W (1994) Tubularized, incised plate urethroplasty for distal hypospadias 151: 464-465. 4) Duckett JW Jr, Kaplan GW, Woodard JR, Devine CJ Jr (1980) Panel: complications of hypospadias repair 7: 443-454. 5) Braga LHP, Lorenzo AJ, Pippi Salle JL. Tubularized incised plate urethroplasty for distal hypospadias: A literature review. Indian J Urol 2008 Apr; 24(2)219-25. 6) Allen TD,Spence HM: The Surgical Treatment Of Coronal hypospadias and related problems , J. Urol 100:504, 1968. 7) Holland AJA, Smith GHH, Ross Fl, et al. HOSE: an objective scoring system for evaluating the results of hypospadias surgery. BJU Int 2001;88:255-8. 8) Hinman F. Penis: Plastic operation. In: Atlas of urologic surgery 2nd ed. Philadelphia; WB Saunders, 1998:96-157. 9) Abdul-Ghafoor B, Al-Dabbagh H. Primary distal hypospadias repair: tubularized incised plate urethroplasty (Snodgrass) versus the perimeatal based flap (Mathieu). Iraqi J Com Med 2009; 23-1. Rabnowitz R. and Hulbert W.C: Meatal-based flap Mathieu procedure. Adult and Pediatric. Saunders, Philadelphia, pp 39-43, 1999

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPH repair outcome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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