Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions

Aortic Dissection Clinical Trial

— Mini-Bentall  

Official title:

Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions: an Investigator-initiated, Single-center, Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177548
• Other study ID #: XJTU1AF2023LSK-434
• Status: Recruiting
• Start date: December 11, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yan Yang
• Phone: +86.29.85323869
• Email: yangyan3[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study intends to include patients who had aortic root lesions and were treated with Bentall surgery from January 2019 to July 2023 in the First Affiliated Hospital of Xi'an Jiaotong University. The patients will be divided into the minimally invasive group and control group according to the surgical methods: the former underwent minimally invasive Bentall surgery through a small right intercostal incision; the latter underwent traditional Bentall surgery through a median sternal incision. By comparing the clinical data of patients in two groups, we will investigate the effect and safety of minimally invasive Bentall surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 28, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who were diagnosed with aortic root lesions and treated with the Bentall procedure at the First Affiliated Hospital of Xi'an Jiaotong University from January 2019 to July 2023 will be included in this study.

Exclusion Criteria:

• Previous sternotomy or aortic root surgery;
• Combined coronary artery disease requiring simultaneous coronary revascularization;
• Combined aortic arch lesions requiring simultaneous aortic arch surgery;
• Preoperative comorbidities with severe single or multiple organ failure;
• Incomplete clinical information;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Dissection
• Aortic Root Aneurysm
• Minimally Invasive Surgical Procedures

Intervention

Procedure:
• Minimally invasive Bentall procedure
The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiantong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate	It focuses on the mortality rate of all patients after the operation after 30 days. The data will be obtained from medical records.	1-month after the operation.
Secondary	Mortality rate during hospitalization	It focuses on the mortality rate of all patients after the operation during hospitalization. The data will be obtained from medical records.	About 10 days after the operation.
Secondary	Blood transfusion volume during hospitalization	It focuses on the blood transfusion volumes of all patients after the operation during hospitalization. The data will be obtained from medical records.	About 10 days after the operation.
Secondary	Postoperative ICU length of stay	It focuses on the ICU length of stay of all patients after the operation. The data will be obtained from medical records.	About 3 days after the operation.
Secondary	Postoperative ventilation time	It focuses on the postoperative ventilation time of all patients after the operation. The data will be obtained from medical records.	About 1 day after the operation.