Nutrition Support for Hirschsprung Disease

NCT ID: NCT04598841

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrition Supporting Hirschsprung Disease Infants Prospective Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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intervention group

Intravenous nutrition or oral high-calorie diet 7-10 days before surgery

Group Type EXPERIMENTAL

supplement nutritional supporting

Intervention Type DIETARY_SUPPLEMENT

Special medical formula for the purpose of formula food

control group

normal diet before surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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supplement nutritional supporting

Special medical formula for the purpose of formula food

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiexiong Feng

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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TJH-HSCRNS

Identifier Type: -

Identifier Source: org_study_id

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