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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection; Minimally Invasive Surgical Procedures; Aortic Root Aneurysm
• Intervention / Treatment: Procedure: Minimally invasive Bentall procedure

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Li Guoliang; Phone Number: +86.29.85323869; Email: liguoliang_med@163.com
• Study Contact Backup: Name: Yan Yang; Phone Number: +86.29.85323869; Email: yangyan3@xjtu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xi'an Jiantong University
      • Contact: Guoliang Li; Phone Number: 008613759982523; Email: liguoliang_med@163.com
      • Contact: Yang Yan; Phone Number: +86.29.85323869; Email: yangyan3@xjtu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minimally invasive Group; Patients who underwent minimally invasive Bentall procedure will be included. The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.	Procedure: Minimally invasive Bentall procedure; The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.
Control Group; Patient who underwent Bentall procedure through median sternotomy will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): October 25, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Aortic Aneurysm; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Aneurysm, Thoracic; Aortic Dissection; Aortic Root Aneurysm
• Other Study ID Numbers: XJTU1AF2023LSK-434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No