An observational study in Chest Wall Deformity, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Patients requiring thoracic reconstruction often suffer from numerous comorbidities, such as obesity, diabetes, atherosclerosis and cardiovascular diseases, respiratory diseases. The clinical picture of these patients must be carefully stabilized in the preoperative period since the listed diseases are associated with a poor reconstructive outcome. Furthermore, it is necessary to preoperatively determine the spirometric characteristics in cases where the intervention may alter the respiratory dynamics to evaluate the patient's ability to tolerate the procedure. The primary objective of the study is to identify the best diagnostic-therapeutic approach in cases of complex chest wall defects, retrospectively evaluating the outcomes and therapeutic choices implemented, through a reassessment of the interventions performed and the clinical progress of patients undergoing complex thoracic and sternal reconstruction interventions managed in a multidisciplinary and non-multidisciplinary manner
Currently there are no univocal universally accepted guidelines regarding the intervention to be performed in case of complex chest wall reconstructions or for the treatment of sternal wound dehiscences. Different options are described, both for the demolition phase and for the reconstructive phase in the thoracic and sternal area. The choice of one method rather than the other is currently largely based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive, reconstructive, pharmacological) on patients treated at the AOU Sant'Orsola (now IRCCS) in past years. The secondary objective of the study is to improve the multidisciplinary management of patients who are candidates for complex chest reconstructions.
In particular, the drafting of a multidisciplinary therapeutic protocol that uses algorithms to optimize the choice of surgical procedure and medical therapy in terms of resolution of the problem, hospitalization times, and patient quality of life.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients meeting the inclusion criteria will be counted, starting from January 1, 2010 to January 1, 2023.
It is estimated that approximately 100 patients will meet the inclusion criteria.
Exclusion Criteria:
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Technical Success
Thechnical success is evaluated by duration of surgery, complications and need for reoperation, and hospitalization time
Time frame: From the first patient enrolled, up to the 100th patient
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IRCCS Azienda Ospedaliero-Universitaria di Bologna