A Trial on Conservative Treatment for Infants' Hirschsprung Disease

Early Phase 1CompletedNCT01985646

Tongji Hospital48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hirschsprung Disease

Interventions

surgery treatmentPROCEDURE

one staged pull-through left-colectomy

anal dilationBEHAVIORAL

anal dilation

colonic lavageBEHAVIORAL

colonic lavage

oral probiotic

Eligibility

Sex: ALLMax age: 3 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

the change of defecation frequence

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

Time frame: 6~12 months

Secondary Outcomes

stool pattern

stool pattern as Forming soft stool or Loose stool

Time frame: 6~12 months

controlling defecation ability

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

Time frame: 6~12 months

complications

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

Time frame: 6~12 months

Data from ClinicalTrials.gov

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