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临床试验/NCT07086963
NCT07086963招募中不适用

Is Dorsal Inlay Graft (DIG) With TIP Repair Superior to TIP Alone for Primary Hypospadias? A Randomized Clinical Trial

Mohammad Daboos1 个研究点 分布在 1 个国家目标入组 584 人开始时间: 2023年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
584
试验地点
1
主要终点
Surgical outcomes

研究概览

简要总结

This prospective, randomized study included all patients who presented with primary hypospadias without chordee, Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.

the investigators aimed to investigate whether GIP with TIP repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.

详细描述

This prospective, randomized study included all patients who presented with primary hypospadias without chordee.

investigators aimed to investigate whether grafted inlay patch with Tabularized Incised Plate repair is superior to TIP, as described by Snodgrass in different types of UP and to provide an overview of the technical aspects of current TIP repair practices.

Patients were randomized into two groups as group 1 or group 2,Group 1: Repaired with standard TIP repair as described by Snodgrass Group 2: Repaired with TIP with GIP using preputial graft. Patients were randomized into two groups using sealed envelopes labeled as group 1 or group 2, selected by the operating theater chief nurse. An independent statistician approved the sample size.

In both groups the functional outcomes were primarily compared regarding meatal position, shape, and the functional outcomes of the neourethra, in addition to other complications such as UCF, wound complications, cosmetic results and the need for a second surgery.

The first visit occurred on the 5th postoperative day. On 2nd week, the patients attended for catheter removal after complete healing. Calibration was performed one week after catheter removal, followed by monthly for the first six months, with HOSE scoring conducted after six months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 120 Months(Child)
性别
Male
接受健康志愿者
否

入选标准

  • •Primary hypospadias candidates for one-stage repair
  • •Uncircumcised cases
  • •Pediatric age group
  • •Patients with regular follow up

排除标准

  • •The presence of chordee or urethral anomalies requiring division of the urethral plate or staged repair
  • •Small glans < 11mm
  • •glanular hypospadias

研究组 & 干预措施

Group 1

Active Comparator

Repaired with standard Tubularized incised plate repair as described by Snodgrass

干预措施: Repaired with standard TIP repair as described by Snodgrass (Procedure)

Group 2

Active Comparator

Repaired with Grafted Tubularized incised plate repair using preputial graft

干预措施: Repaired with TIP with GIP using preputial graft (Procedure)

结局指标

主要结局

Surgical outcomes

时间窗: 6 months

complications rates

cosmetic results

时间窗: 6 months

cosmetic results with Hypospadias Objective Scoring Evaluation.

Functional outcomes

时间窗: 6 months

Urine Flow from the neourethra

次要结局

未报告次要终点

研究者

发起方
Mohammad Daboos
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad Daboos

Assistant professor of pediatric surgery, Pediatric Surgery Department, Al-Azhar University.

Al-Azhar University

研究点 (1)

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