Mini-invasive Approaches to Aortic Surgery

Recruiting

• Conditions: Surgery; Surgical Procedure, Unspecified; Surgical Incision; Aortic Surgery; Surgical Injury
• Interventions: Procedure: Aortic Surgery

• Registration Number: NCT04350697
• Lead Sponsor: University of Florence

Brief 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. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-17
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2425

Inclusion Criteria

• Indication for Aortic and/or Aortic Valve surgery

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mini-Sternotomy	Aortic Surgery	Patients underwent aortic surgery by Mini-Sternotomy
Mini-Thoracotomy	Aortic Surgery	Patients underwent aortic surgery by Mini-Thoracotomy

Primary Outcome Measures

Name	Time	Method
PO	1 day after surgery	Post-Operative Survival

Secondary Outcome Measures

Name	Time	Method
EO	1 month after surgery	Early Outcome (Survival)
MO	5 years after surgery	Mid-term Outcome (Survival)
LO	10 years after surgery	Late Outcome (Survival)
VLO	20 years after surgery	Very-Late Outcome (Survival)

Trial Locations

Locations (1)

Massimo Bonacchi; 🇮🇹 Florence, Italy