Trial record 1 of 8 for:    "Hirschsprungs disease"
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A Trial on Conservative Treatment for Infants' Hirschsprung Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital
ClinicalTrials.gov Identifier:
NCT01985646
First received: October 31, 2013
Last updated: November 10, 2013
Last verified: November 2013
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Tongji Hospital:

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


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

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

  • complications [ Time Frame: 6~12 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Jiexiong Feng, professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT01985646     History of Changes
Other Study ID Numbers: 001, 20090302
Study First Received: October 31, 2013
Last Updated: November 10, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014