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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350088
Recruitment Status : Unknown
Verified January 2015 by Jiexiong Feng, Tongji Hospital.
Recruitment status was:  Recruiting
First Posted : January 29, 2015
Last Update Posted : January 29, 2015
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Study Description
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Brief Summary:
To evaluate the safety and efficacy of Hirschsprung's disease

Condition or disease Intervention/treatment Phase
Surgery Drug: probiotics Drug: placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fast-track Surgery in the Treatment of Hirschsprung's Disease
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fast-track Surgery
probiotics,oral,b.i.d.
 Drug: probiotics
probiotics
Other Name: Bifico
Active Comparator: Traditional Group
placebo,oral,b.i.d.
 Drug: placebo
placebo
Other Name: Bifico


Outcome Measures
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Primary Outcome Measures :
  1. number of participants with recovery of boewl movements [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Duration of the hospital stay [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350088


Contacts
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Contact: Zhi Li, MD PhD +8613387664883 lizhimdphd@163.com

Locations
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China, Hubei
Tongji Hospital Recruiting
Wuhan, Hubei, China, 430030
Contact: Zhi Li, MD PhD    13387664883    lizhimdphd@163.com   
Sponsors and Collaborators
Tongji Hospital
Boston Children's Hospital
Investigators
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Principal Investigator: Zhi Li, MD PhD Tongji Hospital
More Information
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Responsible Party: Jiexiong Feng, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02350088    
Other Study ID Numbers: Tongji Fast-track surgery
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by Jiexiong Feng, Tongji Hospital:
fast-track surgery
Additional relevant MeSH terms:
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Hirschsprung Disease
Digestive System Abnormalities
Digestive System Diseases
Megacolon
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities