Reconstructions of Chest Wall Defects: a Retrospective Study

NCT06774755 | Recruiting

• 1 other identifier: PLAST-CHEST
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chest Wall Deformity

Outcome Measures

Primary Outcomes (1)

• Technical Success

  Thechnical success is evaluated by duration of surgery, complications and need for reoperation, and hospitalization time

  From the first patient enrolled, up to the 100th patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

RECRUITING

Study Officials

• Marco Pignatti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Pignatti, MD

CONTACT

+390512143614; marco.pignatti@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: August 2, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-12

Locations

IT (1)