Clinical trial NCT06448728: Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs
Official title: Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic
Keywords: Thoracic Wall Reconstruction
Surgical Implantation
Reconstruction Materials
Codubix® Ribs Prosthesis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study collects and evaluates retrospective data of approximately 14 patients who underwent full-thickness thoracic wall resection and reconstruction with Codubix® Ribs starting on February 25th, 2018 up to December 31st, 2023 at the thoracic surgery department of the University Hospital of Basel.

Brief summary: The aim of this observational study is to analyze the short- and long-term outcome after surgical implantation of the Codubix® Ribs prosthesis in a descriptive and non-statistical way.

Detailed description: An intact thoracic wall is essential for maintaining organ and respiratory function and upper extremity mobility, and therefore may require surgical intervention if portions of the thoracic wall have been destroyed or removed. Thoracic wall reconstruction is typically needed for cancers originating in or invading the chest wall or for large defects resulting from surgery that removes multiple ribs or the sternum. Less commonly, it is required due to malformations, infections, radiation injuries, or trauma to maintain respiratory function, protect internal organs, and avoid cosmetic defects.

There are several synthetic, metallic, and biologic materials on the market for thoracic wall reconstruction, each with its advantages and disadvantages, and none has proven superior to the others, often being chosen based on the surgeon's experience and preference. Codubix® Ribs, a knitted prosthesis made of polypropylene and polyester yarn, has been used since 2018 for thoracic wall reconstruction due to its high strength, low weight, and non-reactive properties. Moreover, it is radiolucent, easily adjustable to the chest wall's curvature, and maintain enough stiffness to not require additional materials, even for large defects. Although well-established in neurosurgery, its use in thoracic surgery is relatively new and not yet extensively reviewed in literature.

The primary objective is to evaluate the postoperative outcomes after thoracic wall reconstruction with Codubix® Ribs examining mobility, stability, aesthetic outcome and pain. The secondary objectives are to evaluate specific indications for chest wall resection found in the participants and in-hospital complications during the hospital stay.

The results of this study, summarizing our experiences with the relatively unknown prosthesis Codubix Ribs, aim to provide valuable insights and contribute to the broader knowledge base of the medical community regarding effective thoracic wall reconstruction materials.

Eligibility criteria: Inclusion Criteria:

* Patients that received full thickness resection of the thoracic wall and reconstruction using Codubix® Ribs
* Patients of all co-morbidities and gender
* Patients that signed written informed consent according to ICH-GCP regulations prior to initiation of any protocol-specific follow-up events
* Patients of age \>18 years at the time of informed consent

Exclusion Criteria:

* Patients who have not signed hospital's general consent form for the use of their health-related data for scientific purposes will not be included into the project.
* Patients that received thoracic wall reconstruction with other materials than Codubix® Ribs
* Inability to follow procedures or insufficient knowledge of language
* Inability to give consent

Primary outcomes:
measure: Assessment of mobility
timeFrame: At least 3 months post surgery
measure: Physical examination
timeFrame: At least 3 months post surgery
measure: Assessment of disability and symptoms
timeFrame: At least 3 months post surgery
measure: Assessment of pain
timeFrame: At least 3 months post surgery
Secondary outcomes:
measure: Details on thoracic wall resection
timeFrame: At least 3 months post surgery
measure: Risk of mortality
timeFrame: At least 3 months post surgery
measure: Number of in-hospital complications
timeFrame: At least 3 months post surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Clinic for Thoracic Surgery
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Meret Appel
role: PRINCIPAL_INVESTIGATOR
References: