Distal Hypospadias Repair Outcome

NCT06700629 | Not Yet Recruiting

• 1 other identifier: DPH repair outcome
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Distal Penile Hypospadias (Disorder)

Keywords

Penile Hypospadias

Outcome Measures

Primary Outcomes (1)

• Functional outcome of Distal Penile Hypospadias Repair

  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 Outcomes (3)

• Cosmetic outcome of Distal Penile Hypospadias Repair

  Six months postoperatively

• Complication Rate Following Distal Hypospadias Repair

  Weekly assessments during the first month and monthly assessments for the following five months postoperatively.

• Patient-Reported Outcomes

  Six months postoperatively

Study Arms (1)

DPH repair outcome

OTHER

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)

Interventions

Distal Penile Hypospadias (Disorder) PROCEDURE

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

Also known as: Distal Penile Hypospadias repair outcome

DPH repair outcome

Eligibility Criteria

• Age: 1 Year+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Armia Ezzat Thabet Azer: lead

Study Sites (2)

Faculty Of Medicine Assiut University

Asyut, Asyut Governorate, 71511, Egypt

Location

Noha Elabody

Asyut, 71111, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Armia Ezzat Thabet Azer, bachelor degree

CONTACT

+201096067142; armia.ezzat@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: November 22, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

EG (2)