A Trial on Conservative Treatment for Infants' Hirschsprung Disease

November 10, 2013 updated by: Jiexiong Feng, Tongji Hospital

A Prospective, Randomized Controlled Trial of Conservative Versus Surgery Treatment of Normal and Short-segment Hirschsprung Disease for Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change of defecation frequence
Time Frame: 6~12 months
the changes of defecation frequence at 6~12 months after treatment
6~12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stool pattern
Time Frame: 6~12 months
stool pattern as Forming soft stool or Loose stool
6~12 months
controlling defecation ability
Time Frame: 6~12 months
whether patients' controlling of defecation be better or not after treatment
6~12 months
complications
Time Frame: 6~12 months
complications were suffered by patients or not, such as enterolitis, anastomotic stenosis etc.
6~12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 10, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 10, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)
  • 20090302 (Other Identifier: TongjiHospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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