Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Application Value of Intercostal Suturing in Preventing Postoperative Thoracoscopic Lung Resection Chest Wall Pulmonary Hernia

NCT06924515

VATS Lung Hernia

ENROLLING_BY_INVITATION NA

Hemodynamic Changes During One Lung Ventilation in Non-intubated Vedio-assisted Thoracoscopic Operations

NCT02123173

Lung Neoplasms

COMPLETED

Preoperative Stereoscopic Localization Versus Methylene Blue Localization in GGO Wedge Resection

NCT03252210

Thoracic Surgery, Video-Assisted

UNKNOWN NA

Lung Transplantation in Respiratory Failure Patients

NCT00854165

Respiratory Failure

UNKNOWN

Tubeless Surgery With Impaired Pulmonary Function

NCT06848751

Lung Function Decreased Surgery

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Anomalous Pulmonary Venous Connection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional surgical group

Patients with total pulmonary venous connection undergo conventional surgical repair

Surgical strategy

Intervention Type PROCEDURE

To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Sutureless surgical group

Patients with total pulmonary venous connection undergo sutureless surgical repair

Surgical strategy

Intervention Type PROCEDURE

To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical strategy

To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No