A Trial on Treatments of Hirschsprung Allied Disease

NCT ID: NCT02212054

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

Conditions

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Complications of Treatment Complication of Surgical Procedure Megacolon, Not Hirschsprung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conservative & operative treatment

anal dilation; colon lavage; probiotics

Group Type EXPERIMENTAL

conservative

Intervention Type BEHAVIORAL

anal dilatation; colonic lavage; oral probiotic

operative treatment

one stage pull- through radical colectomy

Group Type ACTIVE_COMPARATOR

operative

Intervention Type PROCEDURE

one stage pull through radical colectomy

Interventions

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conservative

anal dilatation; colonic lavage; oral probiotic

Intervention Type BEHAVIORAL

operative

one stage pull through radical colectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Feng Jiexiong

Chief of pediatric surgery department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qi T Zhu, PhD

Role: PRINCIPAL_INVESTIGATOR

department of pediatric surgery

Locations

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Department of Pediatric Surgery

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiong J Feng, MD,PhD

Role: CONTACT

0086-27-83665309

Other Identifiers

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101

Identifier Type: -

Identifier Source: org_study_id

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