Trial record 2 of 9 for:    "Hirschsprungs disease"

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014