SurgeryMSvsMTNCT04350697
Mini-invasive Approaches to Aortic Surgery
An observational study of Surgery and Surgical Injury, run by University of Florence at 1 site in Italy.
Trial summary
There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgery, Surgical Injury, Surgical Procedure, Unspecified
- What is being tested?
- Aortic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,425 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 1999to 31 Dec 2025
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing surgery for Aortic and/or Aortic Valve by miniinvasive approaches (ministernotomy or minithoracotomy)
Who may be able to join
- Indication for Aortic and/or Aortic Valve surgery
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Edvin Prifti, Prof contact
Italy1 site, 1 recruiting
- Recruiting
Massimo Bonacchi
Florence, 50144
Massimo Bonacchi, MD, 393389855782, mbonacchi@unifi.it
Sandro Gelsomino, MD
About this study
Official title: Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery
There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.
- Conditions
- Surgery, Surgical Injury, Surgical Procedure, Unspecified, Surgical Incision, Aortic Surgery
- Being tested
- Aortic Surgery
- Keywords
- miniinvasive surgery, aortic surgery, minithoracotomy, ministernotomy, outcomes, surgical complications
- Medical subject headings
- Intraoperative Complications, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic SurgeryProcedure or surgery
Surgery for aortic and/or aortic valve diseases
| Study group | Role | What they receive |
|---|---|---|
| Mini-Sternotomy | Patients underwent aortic surgery by Mini-Sternotomy Receives: Procedure: Aortic Surgery | |
| Mini-Thoracotomy | Patients underwent aortic surgery by Mini-Thoracotomy Receives: Procedure: Aortic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PO
Post-Operative Survival
Measured: 1 day after surgery
Secondary outcomes (4)
EO
Early Outcome (Survival)
Measured: 1 month after surgery
MO
Mid-term Outcome (Survival)
Measured: 5 years after surgery
LO
Late Outcome (Survival)
Measured: 10 years after surgery
VLO
Very-Late Outcome (Survival)
Measured: 20 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jan 1999
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Prof Sandro Gelsomino, Prof Edvin Prifti, Prof Guido Sani, Dr Aleksander Dokollari
- Responsible party
- Principal investigator, Massimo Bonacchi, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350697
- Sponsor's protocol ID
- MSvsMT
- Acronym
- MSvsMT
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonacchi M, Dokollari A, Parise O, Sani G, Prifti E, Bisleri G, Gelsomino S. Ministernotomy compared with right anterior minithoracotomy for aortic valve surgery. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1022-1032.e2. doi: 10.1016/j.jtcvs.2021.03.125. Epub 2021 Apr 23.
PubMed 33994208
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery
- ClinicalTrials.gov ID
- NCT04350697
- Acronym / sponsor ID
- MSvsMT / MSvsMT
- Conditions
- Surgery, Surgical Injury, Surgical Procedure, Unspecified, Surgical Incision, Aortic Surgery
- Keywords
- miniinvasive surgery, aortic surgery, minithoracotomy, ministernotomy, outcomes, surgical complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,425 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Prof Sandro Gelsomino, Prof Edvin Prifti, Prof Guido Sani, Dr Aleksander Dokollari
- Study start
- 1 Jan 1999
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2020 (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.
There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-Sternotomy | – | Procedure: Aortic SurgeryPatients underwent aortic surgery by Mini-Sternotomy |
| Mini-Thoracotomy | – | Procedure: Aortic SurgeryPatients underwent aortic surgery by Mini-Thoracotomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery for Aortic and/or Aortic Valve by miniinvasive approaches (ministernotomy or minithoracotomy)
Key inclusion criteria (1 listed)
- Indication for Aortic and/or Aortic Valve surgery
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Aortic SurgerySurgery for aortic and/or aortic valve diseases | Procedure or surgery | Mini-Sternotomy, Mini-Thoracotomy |
Primary outcome
PO
Time frame: 1 day after surgery
Post-Operative Survival
4 secondary outcomes
EO
Time frame: 1 month after surgery
MO
Time frame: 5 years after surgery
LO
Time frame: 10 years after surgery
VLO
Time frame: 20 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 33994208Bonacchi M, Dokollari A, Parise O, Sani G, Prifti E, Bisleri G, Gelsomino S. Ministernotomy compared with right anterior minithoracotomy for aortic valve surgery. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1022-1032.e2. doi: 10.1016/j.jtcvs.2021.03.125. Epub 2021 Apr 23.
- Individual participant dataSharing planned: No
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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.
Edvin Prifti, Prof contact
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 Surgery and Surgical Injury, run by University of Florence at 1 site in Italy.
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 1 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 28 Apr 2021. 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 Italy. 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 Massimo Bonacchi, Prof (393389855782, mbonacchi@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PO (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350697, which also lists 1 linked publication.
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 28 Apr 2021.