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Nutrition Support for Hirschsprung Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04598841
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Brief Summary:
A multi-center, prospective,randomized, non-blind, controlled study was conducted to investigate the effects of different pre-operative nutritional support modes on perioperative nutritional status, surgical treatment success rate, and rehabilitation process in children with Hirschsprung disease.

Condition or disease Intervention/treatment Phase
Nutrition Supporting Hirschsprung Disease Infants Prospective Study Dietary Supplement: supplement nutritional supporting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: intervention group
Intravenous nutrition or oral high-calorie diet 7-10 days before surgery
Dietary Supplement: supplement nutritional supporting
Special medical formula for the purpose of formula food

No Intervention: control group
normal diet before surgery



Primary Outcome Measures :
  1. rate of postoperative HAEC [ Time Frame: 3 months ]
    Incidence of postoperative HAEC


Secondary Outcome Measures :
  1. Z score [ Time Frame: 3 months ]
    weight/age

  2. LOS [ Time Frame: 1 months ]
    length of postoperative stay

  3. reoperation [ Time Frame: 3 months ]
    rate of reoperation

  4. readmission [ Time Frame: 3 months ]
    rate of readmission



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Ages Eligible for Study:   0 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 0-5 years.
  2. Clinical diagnosis with Hirschsprung's disease who requires surgery;

Exclusion Criteria:

  1. Complicated with severe complications such as enterocolitis associated with Hirschsprung disease;
  2. History of diseases associated with various organ systems that may be life-threatening;
  3. Other severe digestive tract malformations or other diseases that may interfere with the treatment or compliance of the child;
  4. Patients who have participated in other clinical trials within the last 1 month;
  5. Any other conditions in which the investigator considers it inappropriate to participate in the trial.

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): NCT04598841


Contacts
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Contact: Jiexiong Feng 0086-2783665309 fengjiexiong@126.com
Contact: Tianqi Zhu 0086-2783665309 zhutianqi84@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430000
Contact: Tianqi Zhu    0086-27833665309    zhutianqi84@163.com   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Jiexiong Feng, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04598841    
Other Study ID Numbers: TJH-HSCRNS
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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