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A Trial on Conservative Treatment for Infants' Hirschsprung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01985646
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
  Purpose
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

  Eligibility

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
Criteria

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
infants

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