Reconstructions of Chest Wall Defects: a Retrospective Study

Recruiting

• Conditions: Chest Wall Deformity

• Registration Number: NCT06774755
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-08-02
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients undergoing sternal or thoracic reconstruction in collaboration or not with the Reconstructive Plastic Surgery Unit
• Obtaining informed consent

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success	From the first patient enrolled, up to the 100th patient	Thechnical success is evaluated by duration of surgery, complications and need for reoperation, and hospitalization time

Trial Locations

Locations (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola; 🇮🇹 Bologna, Italy