Aortic DissectionMini-BentallNCT06177548
Safety and Efficacy of the Minimally Invasive Bentall Procedure Via a Small Right Intercostal Incision in Patients With Aortic Root Lesions
An observational study of Aortic Dissection and Aortic Root Aneurysm, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection, Aortic Root Aneurysm, Minimally Invasive Surgical Procedures
- What is being tested?
- Minimally invasive Bentall procedure
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2023to 28 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, 008613759982523, liguoliang_med@163.com
Yang Yan, +86.29.85323869, yangyan3@xjtu.edu.cn
About this study
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
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.
- Being tested
- Minimally invasive Bentall procedure
- Medical subject headings
- Aortic Dissection, Aortic Root Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive Bentall procedureProcedure or surgery
The minimally invasive Bentall procedure is performed through a small incision in the right intercostal space.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Minimally invasive Bentall procedure | |
| Control Group | Patient who underwent Bentall procedure through median sternotomy will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-month after the operation.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: About 3 days after the operation.
Postoperative ventilation time
It focuses on the postoperative ventilation time of all patients after the operation. The data will be obtained from medical records.
Measured: About 1 day after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start11 Dec 2023
- Primary completion25 Oct 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177548
- Sponsor's protocol ID
- XJTU1AF2023LSK-434
- Acronym
- Mini-Bentall
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06177548
- Acronym / sponsor ID
- Mini-Bentall / XJTU1AF2023LSK-434
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 25 Oct 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive Group | – | Procedure: Minimally invasive Bentall procedurePatients 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. |
| Control Group | – | –Patient who underwent Bentall procedure through median sternotomy will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive Bentall procedureThe minimally invasive Bentall procedure is performed through a small incision in the right intercostal space. | Procedure or surgery | Minimally invasive Group |
Primary outcome
30-day mortality rate
Time frame: 1-month after the operation.
It focuses on the mortality rate of all patients after the operation after 30 days. The data will be obtained from medical records.
4 secondary outcomes
Mortality rate during hospitalization
Time frame: About 10 days after the operation.
Blood transfusion volume during hospitalization
Time frame: About 10 days after the operation.
Postoperative ICU length of stay
Time frame: About 3 days after the operation.
Postoperative ventilation time
Time frame: About 1 day after the operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection and Aortic Root Aneurysm, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Yang (+86.29.85323869, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality rate (time frame: 1-month after the operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.