Aneurysm
Conditions
Brief summary
The purpose of the registry is to evaluate the peri-operative and short- term outcomes of intercostal nerves cryoablation for post-operative pain control after open thoracic and thoracoabdominal aortic aneurysms repair. The cryoablation procedure is one of the opportunities for pain control after thoracotomy. So, it is routinely performed in major several centers in aortic surgery around the world as a part of the TAA and TAAA procedure. The Registry will include approximately 200 patients treated from January 2022 to January 2024 for thoracic or thoracoabdominal aortic aneurysm by means of open surgery and in whom intraoperative intercostal nerves cryoablation will be performed; to reach 200 patients, the enrolments can be extended until January 2027.
Interventions
PROCEDUREOpen thoracic (TAA) and thoracoabdominal aortic aneurysms repair (TAAA)
Each participating center will be able to use its preferred European Conformity marked device, for cryoablation according to their normal clinical practice and according to the instructions for use.
Sponsors
Germano Melissano
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients ≥18 years * Patients who will undergo TAA and TAAA open repair with intraoperative intercostal nerves cryoablation * Subject has consented for study participation and signed the approved Informed Consent
Exclusion criteria
* Patients with active systemic or cutaneous infection or inflammation * Patients who are pregnant or breastfeeding * Patients younger than 18 years of age * Unwilling or unable to comply with the follow-up schedule * Inability or refusal to give informed consent * Frank rupture * Previous stroke with neurological sequelae
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary clinical success | up to 3 weeks | pain control defined as a visual analogic scale \< 5 in the perioperative period up to the discharge |
| technical success | From Admission to 1 years | Freedom from Death |
| change in dose of narcotic administration | From Admission to 1 years | reduction opioids usage for thoracic incision pain |
| secondary clinical success | up to 3 weeks | pain control in in the perioperative period up to the discharge, using analgesic non opioids drugs |
Countries
Austria, France, Germany, Italy, Netherlands, Portugal, Switzerland, United Kingdom
Outcome results
None listed