Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02342457 |
| Other study ID # |
0274-13-RMC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
December 3, 2014 |
| Last updated |
January 20, 2015 |
| Start date |
March 2015 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
January 2015 |
| Source |
Rabin Medical Center |
| Contact |
Enrique Freud, MD |
| Phone |
+972-3-9253737 |
| Email |
freuden[@]clalit.org.il |
| Is FDA regulated |
No |
| Health authority |
Israel: Ministry of Health |
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
