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临床试验/NCT02342457
NCT02342457Unknown不适用

The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.

Rabin Medical Center0 个研究点目标入组 20 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Characteristic electrophysiologic curve for aganglionated bowel

研究概览

简要总结

Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed.

详细描述

Hirschsprungs disease is found in 1:5000 newborns, the disease is caused by aganglionosis of the colon, leading to severe constipation and possible bowel obstruction. The diagnosis is based on leveling biopsies taken from the rectum and colon. Treatment is supportive if complications had arisen, and surgical for definitive correction of the pathophysiological condition which is the cause of the disease. Currently, clinicians rely on histopathology, for diagnosing the disease, and planning surgical correction. The main goal of Surgical treatment will be the creation of a continuous patent and innervated bowel, in which effective propulsive peristalsis is taking place. This is achieved by resection of aganglionic colon, and anastomosis of normal colon with normal ganglia, to anus. Today surgeons await histopathology report for the diagnosis of Hirschsprungs disease, and frozen section biopsies taken when in surgery to ascertain the level of ganglionated bowel.

In this study the investigators aim to correlate electrophysiological reading, from colon suspected of Hirschsprungs disease. If correlation is found, or a specific pattern which is diagnostic of the disease may be found, the electrophysiological study may offer a new way of diagnosing the disease, which is not invasive and allows prompt diagnosis in contrast to histopathology which is time consuming. A reliable electrophysiological study for Hirschsprungs disease may be helpful in early and correct diagnosis, with a noninvasive procedure as compared to a biopsy of the colonic wall. Children with chronic constipation, suspected of having hirschsprungs disease, who are admitted for rectal biopsy will be included in the study. During the procedure, electrophysiological reading from the site chosen for biopsy will be done. Correlation between electrophysiological data and histopathology will be analyzed. The actual reading will be carried out by a custom made electrode by GAELTEC DEVICES LTD : DUNVEGAN : ISLE OF SKYE : SCOTLAND.

研究设计

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

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out

排除标准

  • 未提供

结局指标

主要结局

Characteristic electrophysiologic curve for aganglionated bowel

时间窗: 2 years

次要结局

未报告次要终点

研究者

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

Naftali Freud

Head of peadiatric surgery

Rabin Medical Center

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