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

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ClinicalTrials.gov Identifier: NCT02234219
Recruitment Status : Recruiting
First Posted : September 9, 2014
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jiexiong Feng, Tongji Hospital

Brief Summary:
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

Condition or disease Intervention/treatment Phase
Constipation Procedure: Heart-shape anastomosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Actual Study Start Date : November 30, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2024


Arm Intervention/treatment
Active Comparator: Circular Anastomosis Procedure: Heart-shape anastomosis
a new operation approach for Hirschsprung disease

Active Comparator: Heart-shaped Anastomosis Procedure: Heart-shape anastomosis
a new operation approach for Hirschsprung disease




Primary Outcome Measures :
  1. Postoperative cure rate [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Postoperative complication rate [ Time Frame: two years ]


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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02234219


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
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Responsible Party: Jiexiong Feng, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT02234219    
Other Study ID Numbers: Anastomosis in Hirschsprung
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hirschsprung Disease
Constipation
Signs and Symptoms, Digestive
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities