Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

NCT04234711 | Unknown DMC

• 1 other identifier: 20190505
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.

Conditions

Total Anomalous Pulmonary Venous Connection

Keywords

TAPVC; Surgical strategy; PVO; outcomes

Outcome Measures

Primary Outcomes (2)

• Incidence rate of postoperative pulmonary venous obstruction (PVO)

  in anastomosis or arborizations of pulmonary veins

  2 years

• Mortality rate

  all causes and surgical repair related

  2 years

Secondary Outcomes (4)

• The scores of postoperative quality of life: rating scale

  2 years

• Change in resting oxygen saturation

  2 years

• Value of tricuspid annular plane systolic excursion

  2 years

• Development of all kinds of arrhythmia

  2 years

Study Arms (2)

Conventional surgical group

Patients with total pulmonary venous connection undergo conventional surgical repair

Procedure: Surgical strategy

Sutureless surgical group

Patients with total pulmonary venous connection undergo sutureless surgical repair

Procedure: Surgical strategy

Interventions

Surgical strategy PROCEDURE

To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Conventional surgical group; Sutureless surgical group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants undergoing initial operation for total anomalous pulmonary venous connection in the participating hospitals of this study.

You may qualify if:

• Infants and neonates who are diagnosed with TAPVC
• Infants and neonates who undergo initial surgical repair for TAPVC.

You may not qualify if:

• Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
• Older than 1-year-old.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 520000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Common pulmonary vein tissue for histopathology of abnormal vein

MeSH Terms

Conditions

Scimitar Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory System Abnormalities; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jian Zhuang, M.D., Ph D.

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Rong Liufu, M.D.

CONTACT

020-83827812; liufurong103@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 21, 2020
• Study Start: February 20, 2020
• Primary Completion: August 31, 2021
• Study Completion: February 1, 2022
• Last Updated: February 11, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)