Total anomalous pulmonary venous connection
Conditions
Interventions
sutureless technique group:sutureless technique
conventional repair group :conventional repair
Sponsors
Shanghai Children's Medical Center,Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated informed consent form ( Stated willingness to comply with all study procedures and availability for the duration of the study); 2. Children under 18 years old, regardless of gender; 3. TAPVC patients diagnosed with surgery and at high risk of PVS predicted by the model; 4. The preoperative color Doppler ultrasound indicated that the left ventricular ejection fraction (LVEF) >=50%; 5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 years after the end of the study intervention administration; 6. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner; 7. Abstain from strenuous exercise for 2 years after surgery. Participants may participate in light recreational activities during studies (e.g., watching television, reading); 8. Abstain from caffeine-,nicotine-, or alcohol-containing products for 2 years after surgery.
Exclusion criteria
Exclusion criteria: 1. TAPVC patients with an anatomical or functional single ventricle; 2. Patients with contraindications to the use of conventional drugs in postoperative care units; 3. Patients fail to undergo cardiac enhanced CT examination; 4. Patients in need of emergency surgery; 5. Patients with preoperative internal environment disorder, acidosis, and multiple organ dysfunction; 6. Patients in remote areas with low follow-up rates; 7. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative pulmonary vein stenosis;Postoperative death;adverse event rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| cardiac care unit stay;length of ventilator support;hospital stay;cardiopulmonary bypass time;aortic cross-clamping time;Delayed sternal closure;postoperative low cardiac output syndrome;postoperative diaphragmatic plication;postoperative blood endothelin content;Postoperative CT-based computational hemodynamic indexs (such as shear stress distribution, etc.);Postoperative NYHA grade;Postoperative ECG;Postoperative blood routine;Postoperative liver and kidney function;Blood B-type natriuretic peptide;Troponin;Postoperative chest radiograph;Postoperative cardiac ultrasound;Postoperative heart rate;Postoperative heart rhythm;Postoperative blood pressure;Postoperative blood oxygen saturation;Postoperative blood gas analysis; | — |
Countries
China
Contacts
Public ContactHuiwen Chen
Shanghai Children's Medical Center,Shanghai Jiao Tong University School of Medicine
Outcome results
None listed