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A Trial on Conservative Treatment for Infants' Hirschsprung Disease

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 15, 2013
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital
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.

Condition Intervention Phase
Hirschsprung Disease Procedure: surgery treatment Behavioral: anal dilation Behavioral: colonic lavage Drug: oral probiotic Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants

Resource links provided by NLM:

Further study details as provided by Jiexiong Feng, Tongji Hospital:

Primary Outcome Measures:
  • the change of defecation frequence [ Time Frame: 6~12 months ]
    the changes of defecation frequence at 6~12 months after treatment

Secondary Outcome Measures:
  • stool pattern [ Time Frame: 6~12 months ]
    stool pattern as Forming soft stool or Loose stool

  • controlling defecation ability [ Time Frame: 6~12 months ]
    whether patients' controlling of defecation be better or not after treatment

  • complications [ Time Frame: 6~12 months ]
    complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.

Enrollment: 48
Study Start Date: October 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery treatment
one stage pull through left-colectomy
Procedure: surgery treatment
one staged pull-through left-colectomy
Experimental: conservative treatment
anal dilation, colonic lavage, oral probiotic
Behavioral: anal dilation
anal dilation
Behavioral: colonic lavage
colonic lavage
Drug: oral probiotic
oral probiotic


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Jiexiong Feng, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01985646     History of Changes
Other Study ID Numbers: 001
20090302 ( Other Identifier: TongjiHospital )
First Submitted: October 31, 2013
First Posted: November 15, 2013
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Jiexiong Feng, Tongji Hospital:
Hirschsprung disease
conservative treatment
surgery treatment

Additional relevant MeSH terms:
Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities