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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
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hirschsprungs Disease

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 3, 2014
    Last Updated
    January 20, 2015
    Sponsor
    Rabin Medical Center
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    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
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    Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease

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