Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2014
CompletedFirst Posted
Study publicly available on registry
January 21, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 21, 2015
January 1, 2015
2 years
December 3, 2014
January 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Characteristic electrophysiologic curve for aganglionated bowel
2 years
Study Arms (1)
Child suspected of Hirschsprung disease
EXPERIMENTALChildren admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 787484BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrique Freud, MD
Schneider medical center of Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of peadiatric surgery
Study Record Dates
First Submitted
December 3, 2014
First Posted
January 21, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2017
Study Completion
December 1, 2017
Last Updated
January 21, 2015
Record last verified: 2015-01