Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Primary Purpose
Constipation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Heart-shape anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Inclusion Criteria:
- Age<14 years
- Hirschsprung's disease diagnosed by biopsy
- Surgical indication
Exclusion Criteria:
- Age>14 years
- Not Hirschsprung's disease
- Surgical contraindication
Sites / Locations
- Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Circular Anastomosis
Heart-shaped Anastomosis
Arm Description
Outcomes
Primary Outcome Measures
Postoperative cure rate
Secondary Outcome Measures
Postoperative complication rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02234219
Brief Title
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Official Title
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circular Anastomosis
Arm Type
Active Comparator
Arm Title
Heart-shaped Anastomosis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Heart-shape anastomosis
Intervention Description
a new operation approach for Hirschsprung disease
Primary Outcome Measure Information:
Title
Postoperative cure rate
Time Frame
two years
Secondary Outcome Measure Information:
Title
Postoperative complication rate
Time Frame
two years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age<14 years
Hirschsprung's disease diagnosed by biopsy
Surgical indication
Exclusion Criteria:
Age>14 years
Not Hirschsprung's disease
Surgical contraindication
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Li, MD PhD
Phone
13387664883
Email
lizhimdphd@163.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial
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