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

NCT06177548 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-434
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Dissection; Aortic Root Aneurysm; Minimally Invasive Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality rate during hospitalization

  About 10 days after the operation.

• Blood transfusion volume during hospitalization

  About 10 days after the operation.

• Postoperative ICU length of stay

  About 3 days after the operation.

• Postoperative ventilation time

  About 1 day after the operation.

Study Arms (2)

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

Control Group

Patient who underwent Bentall procedure through median sternotomy will be included.

Interventions

Minimally invasive Bentall procedure PROCEDURE

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

Minimally invasive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Aortic Root Aneurysm

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yang

CONTACT

+86.29.85323869; yangyan3@xjtu.edu.cn

Li Guoliang

CONTACT

+86.29.85323869; liguoliang_med@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 11, 2023
• Primary Completion: October 25, 2024
• Study Completion: December 28, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-03

Locations

CN (1)