A Trial on Conservative Treatment for Infants' Hirschsprung Disease

Tongji Hospital

Status and phase: Completed; Early Phase 1

Conditions: Hirschsprung Disease

Treatments: Behavioral: anal dilation; Procedure: surgery treatment; Drug: oral probiotic; Behavioral: colonic lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT01985646

20090302

001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

surgery treatment

Experimental group

Description:

one stage pull through left-colectomy

Treatment:

Procedure: surgery treatment

conservative treatment

Experimental group

Description:

anal dilation, colonic lavage, oral probiotic

Treatment:

Behavioral: anal dilation

Drug: oral probiotic

Behavioral: colonic lavage