Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

• Conditions: Total Anomalous Pulmonary Venous Connection
• Interventions: Procedure: Surgical strategy

• Registration Number: NCT04234711
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed 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.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11
• Study Start: 2020-02-20
• Primary Completion: 2021-08-31
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional surgical group	Surgical strategy	Patients with total pulmonary venous connection undergo conventional surgical repair
Sutureless surgical group	Surgical strategy	Patients with total pulmonary venous connection undergo sutureless surgical repair

Primary Outcome Measures

Name	Time	Method
Incidence rate of postoperative pulmonary venous obstruction (PVO)	2 years	in anastomosis or arborizations of pulmonary veins
Mortality rate	2 years	all causes and surgical repair related

Secondary Outcome Measures

Name	Time	Method
Development of all kinds of arrhythmia	2 years	Measured by electrocardiography
The scores of postoperative quality of life: rating scale	2 years	Fill the rating scale through telephone or other communication
Change in resting oxygen saturation	2 years	Answer question through telephone or other communication
Value of tricuspid annular plane systolic excursion	2 years	Measured by echocardiology from follow-up

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China