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

November 20, 2023 updated by: Jiexiong Feng, Tongji Hospital
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative cure rate
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative complication rate
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2019

Primary Completion (Actual)

October 30, 2023

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimated)

September 9, 2014

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anastomosis in Hirschsprung

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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