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Completed

NCT Number: NCT01985646

A Trial on Conservative Treatment for Infants' Hirschsprung Disease

The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in infants with short or normal-segment Hirschsprung disease.

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Key information

Conditions

Hirschsprung Disease Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Megacolon

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hard or firm stools for twice or less per week
  • Age were from newborn to 3 months
  • Histochemical acetylcholinesterase reaction (AChE) in rectal mucosa was positive
  • The narrowed distal bowel on barium enema was characterized as normal or short-segment Hirschsprung disease with a 24h barium retention

Exclusion criteria

  • Children >3months of age
  • Patients presented severe inflammation or malnutrition, unconsciousness, and symptoms of a ruptured hollow viscus
  • Barium enema showed long-segment or total colonic aganglionic bowel

Treatment and study plan

surgery treatment

Procedure

one staged pull-through left-colectomy

anal dilation

Behavioral

anal dilation

colonic lavage

Behavioral

colonic lavage

oral probiotic

Drug

oral probiotic

Primary outcomes

  1. the change of defecation frequence

    Time frame: 6~12 months

    the changes of defecation frequence at 6~12 months after treatment

Secondary outcomes

  1. stool pattern

    Time frame: 6~12 months

    stool pattern as Forming soft stool or Loose stool

  2. controlling defecation ability

    Time frame: 6~12 months

    whether patients' controlling of defecation be better or not after treatment

  3. complications

    Time frame: 6~12 months

    complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants

Important dates

Study start
2009
Primary completion
2011
First posted
Nov 15, 2013
Registry last updated
Nov 15, 2013

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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