Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Unknown

Conditions: Total Anomalous Pulmonary Venous Connection

Treatments: Procedure: Surgical strategy

Study type: Observational

Funder types: Other

Identifiers

NCT04234711

20190505

Details and patient eligibility

About

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

Full description

An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.

Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

150 participants in 2 patient groups

Conventional surgical group

Description:

Patients with total pulmonary venous connection undergo conventional surgical repair

Treatment:

Procedure: Surgical strategy

Sutureless surgical group

Description:

Patients with total pulmonary venous connection undergo sutureless surgical repair

Treatment:

Procedure: Surgical strategy