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临床试验/NCT07074717
NCT07074717招募中不适用

Penile Skin Versus Buccal Mucosal Graft in Augmentation Urethroplasty for Long Anterior Urethral Stricture: A Prospective Randomized Study

Tanta University1 个研究点 分布在 1 个国家目标入组 80 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
招募中
入组人数
80
试验地点
1
主要终点
Surgical Success Rate

研究概览

简要总结

The aim of this study is to analyze the outcomes of dorsal onlay buccal mucosal graft (BMG) and penile skin graft (PSG) urethroplasty in the management of long segment bulbar urethral stricture.

详细描述

Penile urethral reconstruction proves to be a continuous challenge as no perfect technique is considered for all patients with this problem. Among all the methods used for treatment of urethral stricture, the substitution urethroplasty with tissue transfer using either flap or graft is the gold standard treatment option for long segment urethral strictures.

In 1993, McAninch described a circular fasciocutaneous flap for the management of penile urethral stricture up to 15 cm that showed excellent cosmetic and functional outcomes due to this being a hairless, flexible flap with a rich vascular supply.

Buccal mucosal graft (BMG) was rediscovered and popularized in 1992 by Burger et al., then El-Kassaby et al. in 1993 published a series using buccal mucosal graft to repair anterior urethral stricture. Buccal mucosal graft became an ideal urethral substitute due to easy harvesting, hairlessness and compatibility in a wet environment.

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
None

入排标准

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

入选标准

  • •Patients with long segment anterior urethral stricture that was defined as a stricture with a length of more than 1 cm with spongiofibrosis.
  • •Patients with previous failed urethral dilatation or direct vision internal urethrotomy (DVIU)

排除标准

  • •Patients with lichen sclerosus
  • •Patients with history of hypospadias repair
  • •Patients with recurrent urethral stricture after failed previous urethroplasty

研究组 & 干预措施

Buccal Mucosal Graft (BMG)

Experimental

Participants will undergo dorsal onlay augmentation urethroplasty using a buccal mucosal graft harvested from the inner cheek. The procedure is performed under spinal or general anesthesia. Graft is sutured dorsally over the strictured urethral segment after excision of the fibrotic tissue.

干预措施: Buccal Mucosal Graft (BMG) Urethroplasty (Procedure)

Penile Skin Graft (PSG)

Experimental

Participants will undergo dorsal onlay augmentation urethroplasty using a penile skin graft harvested from the ventral surface of the penis. The hairless skin is prepared and sutured dorsally over the strictured urethral segment. The procedure is done under spinal or general anesthesia.

干预措施: Penile Skin Graft (PSG) Urethroplasty (Procedure)

结局指标

主要结局

Surgical Success Rate

时间窗: 9 months postoperatively

Success is defined as satisfactory urinary stream with no need for further intervention (such as dilatation or DVIU) and no evidence of stricture on retrograde urethrogram during follow-up.

次要结局

  • International Prostate Symptom Score (IPSS)(9 months postoperatively)
  • Length of Urethral Stricture(Intraoperatively)
  • Postoperative Complications(9 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ibrahim Ahmed Elmaadawy

Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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