Nutrition Support for Hirschsprung Disease

Not Applicable

Completed

• Conditions: Nutrition Supporting; Prospective Study; Hirschsprung Disease; Infants
• Interventions: Dietary Supplement: supplement nutritional supporting

• Registration Number: NCT04598841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-18
• Study First Submitted QC: 2020-10-18
• Study First Posted: 2020-10-22
• Study Start: 2021-01-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	supplement nutritional supporting	Intravenous nutrition or oral high-calorie diet 7-10 days before surgery

Primary Outcome Measures

Name	Time	Method
rate of postoperative HAEC	3 months	Incidence of postoperative HAEC

Secondary Outcome Measures

Name	Time	Method
Z score	3 months	weight/age
LOS	1 months	length of postoperative stay
reoperation	3 months	rate of reoperation
readmission	3 months	rate of readmission

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China