Anal Dilatation for Infants and Children With Constipation

September 30, 2014 updated by: Jiexiong Feng, Tongji Hospital
This study is to evaluate the effect of anal dilation in infants and children with constipation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

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

1 month to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infants and Children With Constipation
  2. Postoperative infants and children with Hirschsprung's disease
  3. Good compliance

Exclusion Criteria:

  1. Infants and Children With Constipation
  2. Poor compliance

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anal dilatation
Drug: Lactulose
Active Comparator: Oral Lactulose
Drug: Lactulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily stool times
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
The frequency of intestinal peristalsis waves
Time Frame: two years
two years
The amplitude of intestinal peristalsis waves
Time Frame: two years
two years

Collaborators and Investigators

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

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Jiexiong, Feng, 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

September 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

September 28, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 3, 2014

Last Update Submitted That Met QC Criteria

September 30, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anal Dilatation

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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