Fast-track Surgery in the Treatment of Hirschsprung's Dis... | NCT02350088

Studies
Fast-track Surgery in the Treatment of Hirschsprung's Disease

NCT02350088

Sponsor

Tongji Hospital

Status

Unknown status

Last Update Posted

Jan 29, 2015Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Surgery

Interventions

probiotics
placebo

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

Jan 2015

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

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jan 17, 2015

First Submission Date that Met QC Criteria

Jan 24, 2015

First Posted Date

Jan 29, 2015Estimated

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

Jan 24, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Name	Class
Boston Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To evaluate the safety and efficacy of Hirschsprung's disease

Detailed Description

The patients are divided into two groups：fast-track surgery combined with laparoscope group and laparoscope with traditional managements group.Postoperative recovery,hospital stay,hospital cost and complcations were compared.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fast-track Surgery	Active Comparator	probiotics,oral,b.i.d.	Drug: probiotics
Traditional Group	Active Comparator	placebo,oral,b.i.d.	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
probiotics	Drug	probiotics	Fast-track Surgery	Bifico

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participants with recovery of boewl movements		one year

Secondary Outcomes

Measure	Description	Time Frame
Duration of the hospital stay		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgical treatment for Hirschsprung's disease
The first procedure for Hirschsprung's disease
Age<14 years

Exclusion Criteria:

conservative treatment for Hirschsprung's disease
The reoperation for Hirschsprung's disease
Age>14 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhi Li, MD PhD	Contact	+8613387664883		lizhimdphd@163.com

Overall Officials

Name	Affiliation	Role
Zhi Li, MD PhD	Tongji Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital	Recruiting	Wuhan	Hubei	430030	China

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided