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A Trial on Conservative Treatment for Infants' Hirschsprung Disease

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ClinicalTrials.gov Identifier: NCT01985646
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : November 15, 2013
Information provided by (Responsible Party):
Jiexiong Feng, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : November 2011

Arm Intervention/treatment
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

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

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

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

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

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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
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Responsible Party: Jiexiong Feng, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01985646    
Other Study ID Numbers: 001
20090302 ( Other Identifier: TongjiHospital )
First Posted: November 15, 2013    Key Record Dates
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:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities