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临床试验/NCT05565040
NCT05565040已完成不适用

Concealed Penis in Pediatric Age Group; A Comparison Between Three Surgical Techniques

Egyptian Biomedical Research Network2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Post-operative appearance of penile skin congestion and/or necrosis

研究概览

简要总结

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by phallopexy only, group B; patients treated by complete dissection and excision of dartos fascia & group C; patients treated by both phallopexy and dartos excision.

详细描述

Background: Comparison between three different surgical techniques in the management of concealed penis. Methods: This prospective interventional non-randomized study included 150 pediatric patients with concealed penis. They were distributed equally into three groups; group A; patients treated by anchoring the penile skin dermis to Buck's fascia at the penile base at 3 & 9 o'clock points using PDS 5/0 (phallopexy), group B; patients treated by complete dissection and excision of dartos fascia & group C; patients treated by phallopexy as in group A after complete dissection and excision of dartos fascia. Follow-up at the end of the 1st post-operative week and then monthly for 6 months as regards penile skin congestion and/or necrosis, wound infection, edema, and/or re-retraction was carried out.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • patients with a buried penis at or below the pubic skin level with a stretched penile length for all of them within the normal range according to their ages as titrated in the literature

排除标准

  • Patients with any associated anomalies like hypospadias, torsion, penoscrotal web, micropenis, mega-prepuce, or chordae were excluded from the study.

结局指标

主要结局

Post-operative appearance of penile skin congestion and/or necrosis

时间窗: 6 months

Repeated and regular monthly examination of the patients as regards persistent bluish penile discoloration and or loss of penile skin viability. Also a questionnaire of parents about penile skin color, loss of skin, and/or appearance of any abnormal tissues

Penile re-retraction

时间窗: 6 months

Repeated and regular monthly examination of the patients as regards the development of any penile re-retraction in the form of retraction of the penis to or beneath the level of pubic skin. Also, a questionnaire of parents about this finding was done

Wound infection

时间窗: 6 months

Repeated and regular monthly examination of the patients as regards the appearance of any penile skin infection and/or pyogenic discharge. Also a questionnaire of parents about the appearance of penile skin redness, pyogenic discharge, and/or the appearance of any pyogenic membranes

Penile edema

时间窗: 6 months

Repeated and regular monthly examination of the patients as regards the appearance of penile skin edema. Also a questionnaire of parents about any increase of penile girth than the usual

次要结局

未报告次要终点

研究者

发起方
Egyptian Biomedical Research Network
申办方类型
Network
责任方
Principal Investigator
主要研究者

Ahmed Elrouby

Associate Professor of Pediatric Surgery, Alexandria University

Egyptian Biomedical Research Network

研究点 (2)

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