A Trial on Treatments of Hirschsprung Allied Disease | NCT02212054

Studies
A Trial on Treatments of Hirschsprung Allied Disease

NCT02212054

Sponsor

Tongji Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Complications of Treatment
Complication of Surgical Procedure
Megacolon, Not Hirschsprung

Interventions

conservative
operative

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Estimated

Primary Completion Date

May 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Aug 6, 2014

First Submission Date that Met QC Criteria

Aug 6, 2014

First Posted Date

Aug 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conservative & operative treatment	Experimental	anal dilation; colon lavage; probiotics	Behavioral: conservative
operative treatment	Active Comparator	one stage pull- through radical colectomy	Procedure: operative

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conservative	Behavioral	anal dilatation; colonic lavage; oral probiotic	conservative & operative treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
stool pattern	stool pattern as hard stool or loose stool	6~12 months
controlling stool ability	whether patients' controlling stool ability is better or not after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiong J Feng, MD,PhD	Contact	0086-27-83665309		31699788@qq.com

Overall Officials

Name	Affiliation	Role
Qi T Zhu, PhD	department of pediatric surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatric Surgery	Recruiting	Wuhan	Hubei	430000	China

Condition Browse Module

MeSH Terms

ID	Term
D008531	Megacolon

Ancestor Terms

ID	Term
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072700	Conservative Treatment

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided