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A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02216994
Recruitment Status : Unknown
Verified October 2014 by Jiexiong Feng, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : August 15, 2014
Last Update Posted : October 28, 2014
Sponsor:
Collaborator:
Jiangxi Province Children's Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Brief Summary:
  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.
  2. 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.

Condition or disease Intervention/treatment Phase
Hirschsprung Disease Drug: high dose lactulose Behavioral: conservative treatment Drug: paraffin oil Not Applicable

Detailed Description:
  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.
  2. 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.
  3. The patients with a predicting score of more than 5 are diagnosed with HD, and are performed surgery to remove the aganglionic bowel.
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : June 2015


Arm Intervention/treatment
surgery treatment
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.
Drug: high dose lactulose
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.
Other Name: Duphalac®

Behavioral: conservative treatment
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.
Other Name: colonic irrigation

Drug: paraffin oil
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.
Other Name: Shilayou®




Primary Outcome Measures :
  1. the predicting score calculation [ Time Frame: 6-12 months ]

    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.

    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 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.



Secondary Outcome Measures :
  1. pathological diagnosis [ Time Frame: 12-18 months ]
    The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.



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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hard or firm stools for 2 or less per week
  • Age are from newborn to 3 years old

Exclusion Criteria:

  • Children>3 years of age
  • Patients presented severe inflammation or malnutrition, unconsciousness or perforation of intestine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216994


Contacts
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Contact: Hongyi Zhang, MD 27-83665209 ext 01186 zhanghongyidoc@foxmail.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Hongyi Zhang, MD    27-83665209 ext 01186    zhanghongyidoc@gmail.com   
Principal Investigator: Jiexiong Feng, MD,PhD         
Sub-Investigator: Jinshi Huang, MD         
Sponsors and Collaborators
Tongji Hospital
Jiangxi Province Children's Hospital
Investigators
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Principal Investigator: Jiexiong Feng, MD, PhD Tongji Medical College,Huazhong University of Science and Technology
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Responsible Party: Jiexiong Feng, Director of pediatric surgery department, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02216994    
Other Study ID Numbers: TJCD-D-13-00074
tj2014701 ( Other Identifier: Tongji Hospital )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Jiexiong Feng, Tongji Hospital:
Intestinal dysganglinosis
Hirschsprung disease
Hirschsprung disease allied disorders
diagnostic scoring system
Prospective study
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities
Mineral Oil
Lactulose
Gastrointestinal Agents
Emollients
Dermatologic Agents