Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05960123
Other study ID # IRB 0000395-24-01-019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date May 30, 2023

Study information

Verified date July 2023
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date May 30, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 14 Years
Eligibility Inclusion Criteria: - lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm Exclusion Criteria: - recurrent cases Proximal; hypospadias

Study Design


Intervention

Procedure:
Tubularized Incised Plate (TIP) urethroplasty
tubularization of urethral plate with or without spongioplasty

Locations

Country Name City State
Egypt Mohammad Daboos Cairo Select

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Cosmetic results Hypospadias Objective Scoring Evaluation (maximum the best is 16 points ) and minimum the worst is 4 12 months
Primary Urethrocutaneous fistula Rate of fistula 12 months
Primary meatal stenosis Rate of metal stenosis 12 months
Primary glans dehiscence Rate of glans dehiscence 12 months
See also
  Status Clinical Trial Phase
Completed NCT02752308 - Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair Phase 2/Phase 3
Completed NCT04239066 - Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes N/A
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Completed NCT03677453 - Interactive Perioperative Teaching Platform (IPTP) N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A