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

Sponsor
Tongji Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02350088
Collaborator
Boston Children's Hospital (Other)
100
Enrollment
1
Location
2
Arms
24
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of Hirschsprung's disease

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fast-track Surgery

probiotics,oral,b.i.d.

Drug: probiotics
probiotics
Other Names:
  • Bifico

    		•
    Active Comparator: Traditional Group

    placebo,oral,b.i.d.

    Drug: placebo
    placebo
    Other Names:
  • Bifico

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of participants with recovery of boewl movements [one year]

    Secondary Outcome Measures

    1. Duration of the hospital stay [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Tongji Hospital
    • Boston Children's Hospital

    Investigators

    • Principal Investigator: Zhi Li, MD PhD, Tongji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiexiong Feng, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT02350088
    Other Study ID Numbers:
    • Tongji Fast-track surgery
    First Posted:
    Jan 29, 2015
    Last Update Posted:
    Jan 29, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Jiexiong Feng, Professor, Tongji Hospital
    fast-track surgery
    Additional relevant MeSH terms:
    Hirschsprung Disease

    Study Results

    No Results Posted as of Jan 29, 2015