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Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234219
Recruitment Status : Recruiting
First Posted : September 9, 2014
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE August 27, 2014
First Posted Date  ICMJE September 9, 2014
Last Update Posted Date September 11, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Postoperative cure rate [ Time Frame: two years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2014)
Postoperative complication rate [ Time Frame: two years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Official Title  ICMJE Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Brief Summary Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE Drug: Probiotics
Study Arms  ICMJE
  • Active Comparator: Circular Anastomosis
    Intervention: Drug: Probiotics
  • Active Comparator: Heart-shaped Anastomosis
    Intervention: Drug: Probiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age<14 years
  2. Hirschsprung's disease diagnosed by biopsy
  3. Surgical indication

Exclusion Criteria:

  1. Age>14 years
  2. Not Hirschsprung's disease
  3. Surgical contraindication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02234219
Other Study ID Numbers  ICMJE Anastomosis in Hirschsprung
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiexiong Feng, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP