Nutrition Support for Hirschsprung Disease

April 3, 2023 updated by: Jiexiong Feng, Tongji Hospital

A Multicentric Study on Pre-operative Nutritional Support for Hirschsprung's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of postoperative HAEC
Time Frame: 3 months
Incidence of postoperative HAEC
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Z score
Time Frame: 3 months
weight/age
3 months
LOS
Time Frame: 1 months
length of postoperative stay
1 months
reoperation
Time Frame: 3 months
rate of reoperation
3 months
readmission
Time Frame: 3 months
rate of readmission
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJH-HSCRNS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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