The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.
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.
Study Type
OBSERVATIONAL
Enrollment
150
To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGIncidence rate of postoperative pulmonary venous obstruction (PVO)
in anastomosis or arborizations of pulmonary veins
Time frame: 2 years
Mortality rate
all causes and surgical repair related
Time frame: 2 years
The scores of postoperative quality of life: rating scale
Fill the rating scale through telephone or other communication
Time frame: 2 years
Change in resting oxygen saturation
Answer question through telephone or other communication
Time frame: 2 years
Value of tricuspid annular plane systolic excursion
Measured by echocardiology from follow-up
Time frame: 2 years
Development of all kinds of arrhythmia
Measured by electrocardiography
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.