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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional surgical group | Patients with total pulmonary venous connection undergo conventional surgical repair |
| |
| Sutureless surgical group | Patients with total pulmonary venous connection undergo sutureless surgical repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical strategy | Procedure | To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of postoperative quality of life: rating scale | Fill the rating scale through telephone or other communication | 2 years |
| Change in resting oxygen saturation | Answer question through telephone or other communication |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates and infants undergoing initial operation for total anomalous pulmonary venous connection in the participating hospitals of this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Liufu, M.D. | Contact | 020-83827812 | liufurong103@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhuang, M.D., Ph D. | Guangdong Provincial People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 520000 | China |
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| ID | Term |
|---|---|
| D012587 | Scimitar Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015619 | Respiratory System Abnormalities |
| D054079 | Vascular Malformations |
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Common pulmonary vein tissue for histopathology of abnormal vein
| 2 years |
| Value of tricuspid annular plane systolic excursion | Measured by echocardiology from follow-up | 2 years |
| Development of all kinds of arrhythmia | Measured by electrocardiography | 2 years |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |