A New Scoring System Improves Diagnostic Accuracy of Intestinal Dysganglionosis --a Prospective Study
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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
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- 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.
Condition or disease | Intervention/treatment | Phase |
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Hirschsprung Disease | Drug: high dose lactulose Behavioral: conservative treatment Drug: paraffin oil | Not Applicable |
- 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.
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.
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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® |
- 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.
- 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: | 1 Day to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Hongyi Zhang, MD | 27-83665209 ext 01186 | zhanghongyidoc@foxmail.com |
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 |
Principal Investigator: | Jiexiong Feng, MD, PhD | Tongji Medical College,Huazhong University of Science and Technology |
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 |
Intestinal dysganglinosis Hirschsprung disease Hirschsprung disease allied disorders diagnostic scoring system Prospective study |
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 |