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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
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

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

First Posted
August 27, 2014
Last Updated
April 25, 2022
Sponsor
Tongji Hospital
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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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