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Completed

NCT Number: NCT04598841

Nutrition Support for Hirschsprung 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.

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Key information

Conditions

Nutrition Supporting Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Hirschsprung Disease Infants Intestinal Diseases Megacolon Prospective Study

Age range

0 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

supplement nutritional supporting

Dietary Supplement

Special medical formula for the purpose of formula food

Primary outcomes

  1. rate of postoperative HAEC

    Time frame: 3 months

    Incidence of postoperative HAEC

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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