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Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease

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ClinicalTrials.gov Identifier: NCT02342457
Recruitment Status : Unknown
Verified January 2015 by Naftali Freud, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 21, 2015
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Naftali Freud, Rabin Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Hirschsprungs Disease Device: Child suspected of Hirschsprung disease Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Child suspected of Hirschsprung disease
Children admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision.
Device: Child suspected of Hirschsprung disease
Children admitted for rectal biopsy, due to chronic constipation and suspected of Hirschsprungs disease, will undergo electrophysiological reading from the rectal inner wall, at thechosen site for biopsy before biopsy is performed. Histopathology and readings will be analyzed for corelation
Other Name: Electrophysiological study of the rectum in children




Primary Outcome Measures :
  1. Characteristic electrophysiologic curve for aganglionated bowel [ Time Frame: 2 years ]


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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342457


Contacts
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Contact: Enrique Freud, MD +972-3-9253737 freuden@clalit.org.il
Contact: Elad Feigin, MD +972-3-9253737 eladf@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Enrique Freud, MD Schneider medical center of Israel

Publications:
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Responsible Party: Naftali Freud, Head of peadiatric surgery, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02342457    
Other Study ID Numbers: 0274-13-RMC
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities