IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138, Italy
NCT Number: NCT06835231
The aim of this study is to evaluate the medium- to long-term results of patients operated with bronchial and/or vascular sleeves. We will also evaluate the differences in terms of complications and medium-term results with patients undergoing pneumonectomy.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Bologna, Emilia-Romagna, 40138, Italy
Many studies have confirmed the validity in functional and prognostic terms of resections lung 'lung-sparing' or 'broncho-vascular sleeve' resections), i.e. with sparing of lung parenchyma.
This concept is applicable to small peripheral neoplasms for which there is increasing use of segmental resections instead of lobar resections, but above all - and this is the subject of the present study - for larger neoplasms and/or neoplasms that develop in the proximity of hilar structures with involvement of vascular-bronchial afferents. They are widely described in the literature as bronchial and vascular reconstruction techniques that allow both the preservation of a significant portion of lung parenchyma and consensually guarantee the surgical procedure's oncological radicality.
In addition to the preservation of a functionally valid and effective portion of the lung, with the unquestionable benefits in terms of quality of life for the patient, this type of technique surgical technique with reconstruction offers an additional advantage, making it possible to avoid sacrificing sacrifice of the entire lung (pneumonectomy procedure), an operation that has a considerably higher morbidity and mortality rate.
However, these techniques can also be associated with complications, some of them specific and inherent to (a) the bronchial anastomosis (which may go into dehiscence or stenosis) or b) arterial plastics (in its different forms and with different types of complications); finally, they are procedures that may entail technical surgical difficulties not negligible and are for this reason usually the prerogative of high-volume thoracic surgery centres.
high-volume thoracic surgery centres.
The scientific literature has often focused on long-term oncological outcomes, many studies are available in this regard. In contrast, fewer studies have focused on the short-to-medium-term results (peri-operative period and period within <5aa) and the quality of life of life experienced by the patient after surgery. For example, the development of stenosis cicatricial stenosis of the bronchial anastomosis as well as other technique-specific issues (effectiveness of pulmonary vascular axis reconstruction) has only rarely been explored in detail.
The aim of this study is to examine the characteristics and risk factors of patients undergoing sleeve surgery who subsequently developed anastomosis stenosis or technical complications in a broader sense and the results in terms of prognosis from an oncological point of view.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 18 months
Rate of postoperative complication
Time frame: through study completion, an average of 18 months
Overall Survival, from the date of surgery to the latest follow up or death
Time frame: through study completion, an average of 18 months
Disease Free Survival, from the date of surgery to the first appearance of local, regional and/or distant recurrence
Time frame: 30 and 90 days from the day of surgery
Mortality rate at 30 and 90 days from the day of surgery
Time frame: 30 days from the date of discharge
Rate of rehospitalization in the first 30 days after discharge
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Broncho-vascular 'Lung Sparing' Reconstructions and Pneumonectomies in Patients With Non-small Cell Lung Cancer (Nsclc): Short-/Medium-term Results and Quality of Life
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