Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-04 @ 2:36 PM
Study NCT ID:
NCT02342457
Status:
UNKNOWN
Last Update Posted:
2015-01-21
First Post:
2014-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006627', 'term': 'Hirschsprung Disease'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008531', 'term': 'Megacolon'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2015-01-20', 'lastUpdatePostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristic electrophysiologic curve for aganglionated bowel', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hirschsprungs Disease']}, 'referencesModule': {'references': [{'pmid': '787484', 'type': 'BACKGROUND', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted for rectal biopsy, by clinical decision, so that Hirschsprungs disease may be diagnosed or ruled out\n\nExclusion Criteria:\n\nNone\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02342457', 'briefTitle': 'Electrophysiological Activity of the Anorectum in Children Suspected of Hirschsprung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Elactrophysiological Response of the Colon, in Normal Bowel, and Large Bowel Lacking Ganglia in Children With Suspected Hirschsprungs Disease.', 'orgStudyIdInfo': {'id': '0274-13-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Child suspected of Hirschsprung disease', 'description': 'Children admitted for biopsy, so that Hirschsprungs desease may be ruled out or diagnosed, whom are planned for rectal biopsy, by clinical decision.', 'interventionNames': ['Device: Child suspected of Hirschsprung disease']}], 'interventions': [{'name': 'Child suspected of Hirschsprung disease', 'type': 'DEVICE', 'otherNames': ['Electrophysiological study of the rectum in children'], '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', 'armGroupLabels': ['Child suspected of Hirschsprung disease']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Enrique Freud, MD', 'role': 'CONTACT', 'email': 'freuden@clalit.org.il', 'phone': '+972-3-9253737'}, {'name': 'Elad Feigin, MD', 'role': 'CONTACT', 'email': 'eladf@clalit.org.il', 'phone': '+972-3-9253737'}], 'overallOfficials': [{'name': 'Enrique Freud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schneider medical center of Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of peadiatric surgery', 'investigatorFullName': 'Naftali Freud', 'investigatorAffiliation': 'Rabin Medical Center'}}}}