Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Trial on Treatments of Hirschsprung Allied Disease

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.
 
ClinicalTrials.gov Identifier: NCT02212054
Recruitment Status : Unknown
Verified August 2014 by Feng Jiexiong, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Feng Jiexiong, Tongji Hospital

Brief Summary:
The present study was designed to compare the efficacy of conservative treatment to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Condition or disease Intervention/treatment Phase
Complications of Treatment Complication of Surgical Procedure Megacolon, Not Hirschsprung Behavioral: conservative Procedure: operative Early Phase 1

Detailed Description:
The present study was designed to compare the efficacy of conservative treatment,such as anal dilatation, colonic lavage and so on, to operative treatment for improvement of constipation symptoms in children with Hirschsprung allied disease

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 Children With Hirschsprung Allied Disease
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: conservative & operative treatment
anal dilation; colon lavage; probiotics
Behavioral: conservative
anal dilatation; colonic lavage; oral probiotic

Active Comparator: operative treatment
one stage pull- through radical colectomy
Procedure: operative
one stage pull through radical colectomy




Primary Outcome Measures :
  1. the change of defecation frequency [ Time Frame: 6~12 months ]
    the changes of defecation frequency at 6~12 months after treatment


Secondary Outcome Measures :
  1. stool pattern [ Time Frame: 6~12 months ]
    stool pattern as hard stool or loose stool

  2. controlling stool ability [ Time Frame: 6~12 months ]
    whether patients' controlling stool ability is better or not after treatment

  3. complications [ Time Frame: 6~12 months ]
    complications were suffered by patients or not



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hard or firm stools for twice or less per week
  • a predicting score of less than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Exclusion Criteria:

  • functional constipation
  • a predicting score of more than 5 refer to literature: Wu, X.J., et al., A new diagnostic scoring system to differentiate Hirschsprung's disease from Hirschsprung's disease-allied disorders in patients with suspected intestinal dysganglionosis. Int J Colorectal Dis, 2013. 28(5): p. 689-96

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212054


Contacts
Layout table for location contacts
Contact: Xiong J Feng, MD,PhD 0086-27-83665309 31699788@qq.com

Locations
Layout table for location information
China, Hubei
Department of Pediatric Surgery Recruiting
Wuhan, Hubei, China, 430000
Sponsors and Collaborators
Tongji Hospital
Investigators
Layout table for investigator information
Principal Investigator: Qi T Zhu, PhD department of pediatric surgery

Layout table for additonal information
Responsible Party: Feng Jiexiong, Chief of pediatric surgery department, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02212054    
Other Study ID Numbers: 101
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases