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

Primary Purpose

Hirschsprung Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high dose lactulose
conservative treatment
paraffin oil
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hirschsprung Disease focused on measuring Intestinal dysganglinosis, Hirschsprung disease, Hirschsprung disease allied disorders, diagnostic scoring system, Prospective study

Eligibility Criteria

1 Day - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

surgery treatment

Arm 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.

Outcomes

Primary Outcome Measures

the predicting score calculation
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

pathological diagnosis
The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.

Full Information

First Posted
August 6, 2014
Last Updated
October 27, 2014
Sponsor
Tongji Hospital
Collaborators
Jiangxi Province Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02216994
Brief Title
A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Jiangxi Province Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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.
Detailed Description
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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hirschsprung Disease
Keywords
Intestinal dysganglinosis, Hirschsprung disease, Hirschsprung disease allied disorders, diagnostic scoring system, Prospective study

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery treatment
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
high dose lactulose
Other Intervention Name(s)
Duphalac®
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
conservative treatment
Other Intervention Name(s)
colonic irrigation
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
paraffin oil
Other Intervention Name(s)
Shilayou®
Intervention 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.
Primary Outcome Measure Information:
Title
the predicting score calculation
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. 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.
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
pathological diagnosis
Description
The intestinal specimens were reviewed by 3 experienced pathologists all of whom had participated in a consensus meeting on diagnostic criteria of IDs.
Time Frame
12-18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyi Zhang, MD
Phone
27-83665209
Ext
01186
Email
zhanghongyidoc@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiexiong Feng, MD, PhD
Organizational Affiliation
Tongji Medical College,Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyi Zhang, MD
Phone
27-83665209
Ext
01186
Email
zhanghongyidoc@gmail.com
First Name & Middle Initial & Last Name & Degree
Jiexiong Feng, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jinshi Huang, MD

12. IPD Sharing Statement

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

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