Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-06-26 @ 4:57 AM
Study NCT ID:
NCT02216994
Status:
UNKNOWN
Last Update Posted:
2014-10-28
First Post:
2014-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007792', 'term': 'Lactulose'}, {'id': 'D000072700', 'term': 'Conservative Treatment'}, {'id': 'D008899', 'term': 'Mineral Oil'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010577', 'term': 'Petrolatum'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the predicting score calculation', 'timeFrame': '6-12 months', 'description': 'The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for IDs are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests.\n\nThe patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.\n\nThe patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.'}], 'secondaryOutcomes': [{'measure': 'pathological diagnosis', 'timeFrame': '12-18 months', 'description': 'The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intestinal dysganglinosis', 'Hirschsprung disease', 'Hirschsprung disease allied disorders', 'diagnostic scoring system', 'Prospective study'], 'conditions': ['Hirschsprung Disease']}, 'descriptionModule': {'briefSummary': '1. The investigators previously reported a simple diagnostic scoring system to differentiate Hirschsprung disease (HD) from Hirschsprung disease allied disorders (HAD) in the patients with suspected intestinal dysganglionosis. In the retrospective study, the investigators concluded that the patients with a predicting score of more than 5 are more likely to be diagnosed with HD, whereas a score less than 5 is mostly indicative of HAD.\n2. Since it is essential to confirm the accuracy and efficacy of the scoring system in a prospective manner before it is used as a standard procedure, this prospective study is designed and performed.', 'detailedDescription': '1. Patients have hard or firm stools for 2 or less per week, and with ages from newborn to 3 years old are recruited in this study.\n2. The recruited patients is undergoing preoperative work-up including barium enema (BE), anorectal manometry (ARM) and histochemical acetylcholinesterase (AChE) staining of rectal mucosa. Known risk factors for intestinal dysganglionosis (IDs) are recorded. The predicting score is calculated by summing the scores of the risk factors and 3 preoperative tests.\n3. The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.\n4. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hard or firm stools for 2 or less per week\n* Age are from newborn to 3 years old\n\nExclusion Criteria:\n\n* Children\\>3 years of age\n* Patients presented severe inflammation or malnutrition, unconsciousness or perforation of intestine'}, 'identificationModule': {'nctId': 'NCT02216994', 'briefTitle': 'A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Efficacy and Accuracy of a New Diagnostic Scoring System to Differentiate Hirschsprung Disease From Hirschsprung Disease Allied Disorders in the Patients With Suspected Intestinal Dysganglinosis: a Prospective Study', 'orgStudyIdInfo': {'id': 'TJCD-D-13-00074'}, 'secondaryIdInfos': [{'id': 'tj2014701', 'type': 'OTHER', 'domain': 'Tongji Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'surgery treatment', 'description': 'The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel. The patients with a score less than 5 are mostly indicative of HAD, and receive conservative treatments that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments. one stage pull through procedure to remove the dysganglionic bowel segments.', 'interventionNames': ['Drug: high dose lactulose', 'Behavioral: conservative treatment', 'Drug: paraffin oil']}], 'interventions': [{'name': 'high dose lactulose', 'type': 'DRUG', 'otherNames': ['Duphalac®'], 'description': 'The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.', 'armGroupLabels': ['surgery treatment']}, {'name': 'conservative treatment', 'type': 'BEHAVIORAL', 'otherNames': ['colonic irrigation'], 'description': 'The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.', 'armGroupLabels': ['surgery treatment']}, {'name': 'paraffin oil', 'type': 'DRUG', 'otherNames': ['Shilayou®'], 'description': 'The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.', 'armGroupLabels': ['surgery treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyi Zhang, MD', 'role': 'CONTACT', 'email': 'zhanghongyidoc@gmail.com', 'phone': '27-83665209', 'phoneExt': '01186'}, {'name': 'Jiexiong Feng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jinshi Huang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Hongyi Zhang, MD', 'role': 'CONTACT', 'email': 'zhanghongyidoc@foxmail.com', 'phone': '27-83665209', 'phoneExt': '01186'}], 'overallOfficials': [{'name': 'Jiexiong Feng, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Medical College,Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Jiangxi Province Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of pediatric surgery department', 'investigatorFullName': 'Jiexiong Feng', 'investigatorAffiliation': 'Tongji Hospital'}}}}