A Trial on Conservative Treatment for Infants' Hirschsprung Disease

Hirschsprung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985646
• Other study ID #: 001
• Secondary ID: 20090302
• Status: Completed
• Phase: Phase 0
• First received: October 31, 2013
• Last updated: November 10, 2013
• Start date: October 2009

Study information

• Verified date: November 2013
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hirschsprung Disease

Intervention

Procedure:
• surgery treatment
one staged pull-through left-colectomy

Behavioral:
• anal dilation
anal dilation
• colonic lavage
colonic lavage

Drug:
• oral probiotic
oral probiotic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of defecation frequence	the changes of defecation frequence at 6~12 months after treatment	6~12 months	Yes
Secondary	stool pattern	stool pattern as Forming soft stool or Loose stool	6~12 months	Yes
Secondary	controlling defecation ability	whether patients' controlling of defecation be better or not after treatment	6~12 months	Yes
Secondary	complications	complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.	6~12 months	Yes