NCT02234219

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
5.2 years until next milestone

Study Start

First participant enrolled

November 30, 2019

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

August 27, 2014

Last Update Submit

April 22, 2026

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • bowel function score

    Ability to control bowel movements, Feeling before bowel movement, Soiling, Defecation frequency, Constipation, Social problem

    2 years

Secondary Outcomes (4)

  • rate of postoperative complication

    1month/6 month/12 month/2 years

  • rate of reoperation

    1month/6 month/12 month/2 years

  • rate of readmission

    1month/6 month/12 month/2 years

  • bowel function score

    1 month/6 month/12 month

Study Arms (2)

Heart-shaped anastomosis

EXPERIMENTAL

Heart shaped anastomosis

Procedure: Heart-shape anastomosis

Circle anastomosis

ACTIVE COMPARATOR

Soave anastomosis

Procedure: Soave anastomosis

Interventions

Heart-shape anastomosisPROCEDURE

a new operation approach for Hirschsprung disease

Heart-shaped anastomosis
Soave anastomosisPROCEDURE

traditional approach for Hirschsprung disease

Circle anastomosis

Eligibility Criteria

Age3 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age\<14 years
  • Hirschsprung's disease diagnosed by biopsy
  • Surgical indication

You may not qualify if:

  • Age\>14 years
  • Not Hirschsprung's disease
  • Surgical contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jiexiong Feng, MD.

    Department of Pediatric surgery, Tongji hospital, HUST, Wuhan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2014

First Posted

September 9, 2014

Study Start

November 30, 2019

Primary Completion

October 30, 2023

Study Completion

October 30, 2025

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

CN(1)