Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs

Thoracic Clinical Trial

Official title:

Surgical Outcome Studies in Thoracic Wall Reconstruction With Codubix® Ribs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06448728
• Other study ID #: 2023-01132; kt24Appel
• Status: Completed
• Start date: August 23, 2023
• Est. completion date: December 18, 2023

Study information

• Verified date: June 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Clinic for Thoracic Surgery	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of mobility	To evaluate mobility of the prosthesis, routine screening for thoracic wall mobility is performed using MRI.	At least 3 months post surgery
Primary	Physical examination	To evaluate the thoracic wall stability and aesthetic outcome, a physical examination is done.	At least 3 months post surgery
Primary	Assessment of disability and symptoms	To assess arm, shoulder and hand disability and symptoms, the QuickDASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire is used. It consists of 11 items that inquire about the individual's ability to perform various activities, such as self-care, work, and recreational activities, as well as the severity of symptoms experienced. It provides a quick and comprehensive assessment of upper extremity function and symptoms, with higher scores on a scale from 0 to 100 indicating greater disability, where 0 represents no disability and 100 represents the most severe disability.	At least 3 months post surgery
Primary	Assessment of pain	To assess the postoperative pain, the Numeric Rating Scale (NRS) is used. The NRS is a commonly used tool for assessing pain intensity,asking the patient to rate their pain on a scale from 0 (no pain) to 10 (worst pain).	At least 3 months post surgery
Secondary	Details on thoracic wall resection	Information on the thoracic wall resection, including indication, surgical approach and, extend of resection performed are collected.	At least 3 months post surgery
Secondary	Risk of mortality	The risk of mortality is evaluated using the Charlson Comorbidity index (CCI). The CCI assigns a score to pre-existing medical conditions, with higher scores on a scale from 0 to 33 indicating a greater burden of comorbidities and a higher risk of mortality.	At least 3 months post surgery
Secondary	Number of in-hospital complications	The number of in-hospital complications is assessed using the Clavien-Dindo Classification and CTCAE v5.0 (Common Terminology Criteria for Adverse Events, version 5.0). Both systems grade and classify the severity of adverse events or complications experienced by patients undergoing treatments or surgeries, ranging from ranging from grade I/1 (mild) to grade V/5 (death).	At least 3 months post surgery