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临床试验/NCT06700629
NCT06700629尚未招募不适用

Preoperative Predictors of Distal Hypospadias Repair Outcome

Armia Ezzat Thabet Azer2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
Functional outcome of Distal Penile Hypospadias Repair

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Distal Penile Hypospadias (Disorder) (Procedure)

结局指标

主要结局

Functional outcome of Distal Penile Hypospadias Repair

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Armia Ezzat Thabet Azer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Armia Ezzat Thabet Azer

Resident physician

Assiut University

研究点 (2)

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