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

Primary Purpose

Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
probiotics
placebo
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring fast-track surgery

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. surgical treatment for Hirschsprung's disease
  2. The first procedure for Hirschsprung's disease
  3. Age<14 years

Exclusion Criteria:

  1. conservative treatment for Hirschsprung's disease
  2. The reoperation for Hirschsprung's disease
  3. Age>14 years

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fast-track Surgery

Traditional Group

Arm Description

probiotics,oral,b.i.d.

placebo,oral,b.i.d.

Outcomes

Primary Outcome Measures

number of participants with recovery of boewl movements

Secondary Outcome Measures

Duration of the hospital stay

Full Information

First Posted
January 17, 2015
Last Updated
January 24, 2015
Sponsor
Tongji Hospital
Collaborators
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02350088
Brief Title
Fast-track Surgery in the Treatment of Hirschsprung's Disease
Acronym
Fast-track
Official Title
Fast-track Surgery in the Treatment of Hirschsprung's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
Collaborators
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
fast-track surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fast-track Surgery
Arm Type
Active Comparator
Arm Description
probiotics,oral,b.i.d.
Arm Title
Traditional Group
Arm Type
Active Comparator
Arm Description
placebo,oral,b.i.d.
Intervention Type
Drug
Intervention Name(s)
probiotics
Other Intervention Name(s)
Bifico
Intervention Description
probiotics
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Bifico
Intervention Description
placebo
Primary Outcome Measure Information:
Title
number of participants with recovery of boewl movements
Time Frame
one year
Secondary Outcome Measure Information:
Title
Duration of the hospital stay
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Li, MD PhD
Phone
+8613387664883
Email
lizhimdphd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi Li, MD PhD
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Li, MD PhD
Phone
13387664883
Email
lizhimdphd@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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