Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
Primary Purpose
Hirschsprungs Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Child suspected of Hirschsprung disease
Sponsored by
About this trial
This is an interventional diagnostic trial for Hirschsprungs Disease
Eligibility Criteria
Inclusion Criteria:
- Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out
Exclusion Criteria:
None
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Child suspected of Hirschsprung disease
Arm Description
Children admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision.
Outcomes
Primary Outcome Measures
Characteristic electrophysiologic curve for aganglionated bowel
Secondary Outcome Measures
Full Information
NCT ID
NCT02342457
First Posted
December 3, 2014
Last Updated
January 20, 2015
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02342457
Brief Title
Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
Official Title
The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirschsprungs Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Child suspected of Hirschsprung disease
Arm Type
Experimental
Arm Description
Children admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision.
Intervention Type
Device
Intervention Name(s)
Child suspected of Hirschsprung disease
Other Intervention Name(s)
Electrophysiological study of the rectum in children
Intervention Description
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
Primary Outcome Measure Information:
Title
Characteristic electrophysiologic curve for aganglionated bowel
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out
Exclusion Criteria:
None
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Freud, MD
Phone
+972-3-9253737
Email
freuden@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Elad Feigin, MD
Phone
+972-3-9253737
Email
eladf@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Freud, MD
Organizational Affiliation
Schneider medical center of Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
787484
Citation
Marin AM, Rivarola A, Garcia H. Electromyography of the rectum and colon in Hirschsprung's disease. J Pediatr Surg. 1976 Aug;11(4):547-552. doi: 10.1016/s0022-3468(76)80010-3.
Results Reference
background
Learn more about this trial
Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
We'll reach out to this number within 24 hrs