Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374745
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-10
Brief Title:
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment The Basel Lymphedema Protocol
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment The Basel Lymphedema Protocol
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema
Detailed Description:
Evidence-based surgical treatment recommendations for lymphedema post breast cancer surgery are practically non-existent In fact the meager literature on this matter takes into account only quality of life or patient reported outcome - if at all In light of the heavy burden imposed upon a large portion of breast cancer survivors by chronic lymphedema the investigators study aims to create an evidence-based treatment protocol - The Basel Lymphedema Protocol - to guide surgeons in taking the best course of action when advising patients engaging in shared-decision and performing surgery to reduce lymphedema post breast cancer treatment Accordingly one of the investigators driving goals is to allow surgeons to one day be able consistently rely on hard data
This study is ultimately based on the investigators intent to further patient welfare To this effect creating an integrated algorithm based on concrete tangible data will not only aid patients by leading to improved treatment of their chronic lymphedema and enabling higher quality of life but it will also bolster access to adequate coverage For at present surgical treatment of lymphedema requires submitting a request for a commitment to cover costs to health insurance providers This is a protracted tedious and - unfortunately - an oftentimes fruitless endeavour However by having a strong factual basis - more scientific data and peer-reviewed studies - such requests gain a much greater chance of success To this end the current study certainly has the capacity to pave the way and set evidence-based standards And lastly the creation and implementation of The Basel Lymphedema Protocol would strongly reflect the tenets and purpose of personalizedprecision medicine - treatment tailored to the unique patient - and by so doing refine resource allocation and cost-effectiveness of the healthcare system
This study is ultimately based on the investigators intent to further patient welfare To this effect creating an integrated algorithm based on concrete tangible data will not only aid patients by leading to improved treatment of their chronic lymphedema and enabling higher quality of life but it will also bolster access to adequate coverage For at present surgical treatment of lymphedema requires submitting a request for a commitment to cover costs to health insurance providers This is a protracted tedious and - unfortunately - an oftentimes fruitless endeavour However by having a strong factual basis - more scientific data and peer-reviewed studies - such requests gain a much greater chance of success To this end the current study certainly has the capacity to pave the way and set evidence-based standards And lastly the creation and implementation of The Basel Lymphedema Protocol would strongly reflect the tenets and purpose of personalizedprecision medicine - treatment tailored to the unique patient - and by so doing refine resource allocation and cost-effectiveness of the healthcare system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None