A Trial on Conservative Treatment for Infants' Hirschsprung Disease

Early Phase 1

Completed

• Conditions: Hirschsprung Disease
• Interventions: Procedure: surgery treatment; Behavioral: anal dilation; Behavioral: colonic lavage; Drug: oral probiotic

• Registration Number: NCT01985646
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2011-11
• Study First Submitted: 2013-10-31
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-10
• Last Update Submitted: 2013-11-10
• Study First Posted: 2013-11-15
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery treatment	surgery treatment	one stage pull through left-colectomy
conservative treatment	anal dilation	anal dilation, colonic lavage, oral probiotic
conservative treatment	colonic lavage	anal dilation, colonic lavage, oral probiotic
conservative treatment	oral probiotic	anal dilation, colonic lavage, oral probiotic

Primary Outcome Measures

Name	Time	Method
the change of defecation frequence	6~12 months	the changes of defecation frequence at 6\~12 months after treatment

Secondary Outcome Measures

Name	Time	Method
stool pattern	6~12 months	stool pattern as Forming soft stool or Loose stool
controlling defecation ability	6~12 months	whether patients' controlling of defecation be better or not after treatment
complications	6~12 months	complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.