跳至主要内容
临床试验/NCT03295175
NCT03295175撤回不适用

Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis, an Observational a Prospective, Descriptive, Observational Study

Hospital Universitario San Ignacio1 个研究点 分布在 1 个国家开始时间: 2017年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Differences in the distribution of the smooth Muscle In Dartos

研究概览

简要总结

Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. A redundant and enlarged foreskin is the main feature of this entity.This congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis.

Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. The investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. With the present study the investigators intended to answer these questions and to open paths for future research in this area.

详细描述

After informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. The urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. Same procedure will be performed with the controls and hypospadias group. Only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male patients scheduled for correction of congenital megaprepuce
  • Male patients scheduled for correction of hypospadias
  • Male patients scheduled for circumcision for non-medical reasons.

排除标准

  • Patients with a history of hypospadias correction.

结局指标

主要结局

Differences in the distribution of the smooth Muscle In Dartos

时间窗: 1 year

Smooth Muscle Fibers

Describe the pattern of smooth muscle in patients with megaprepuce

时间窗: 1 year

Smooth Muscle Fibers

次要结局

  • Describe the pattern of smooth muscle in patients with hypospadias(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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