|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02350088 |
|
Date of registration:
|
17/01/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Fast-track Surgery in the Treatment of Hirschsprung's Disease
Fast-track |
|
Scientific title:
|
Fast-track Surgery in the Treatment of Hirschsprung's Disease |
|
Date of first enrolment:
|
January 2014 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02350088 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Zhi Li, MD PhD |
|
Address:
|
|
|
Telephone:
|
13387664883 |
|
Email:
|
lizhimdphd@163.com |
|
Affiliation:
|
|
|
|
Name:
|
Zhi Li, MD PhD |
|
Address:
|
|
|
Telephone:
|
+8613387664883 |
|
Email:
|
lizhimdphd@163.com |
|
Affiliation:
|
|
|
|
Name:
|
Zhi Li, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Tongji Hospital |
|
|
Key inclusion & exclusion criteria
|
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
Age minimum:
1 Year
Age maximum:
18 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Surgery
|
|
Intervention(s)
|
|
Drug: placebo
|
|
Drug: probiotics
|
|
Primary Outcome(s)
|
|
number of participants with recovery of boewl movements
[Time Frame: one year]
|
|
Secondary Outcome(s)
|
|
Duration of the hospital stay
[Time Frame: one year]
|
|
Secondary ID(s)
|
|
Tongji Fast-track surgery
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|