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| Name | Class |
|---|---|
| Sana Kliniken Düsseldorf GmbH | UNKNOWN |
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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.
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 personalized/precision medicine - treatment tailored to the unique patient - and by so doing, refine resource allocation and cost-effectiveness of the healthcare system.
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| Measure | Description | Time Frame |
|---|---|---|
| To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. | To design an integrated algorithm for surgical treatment of chronic cancer-associated lymphedema using the following variables captured in Primary Outcomes 2 to 21. | baseline to follow up (no later than December 2024) |
| Date of follow-up procedure | Date of follow-up procedure. | baseline to follow up (no later than December 2024) |
| Follow-up and type of lymphedema surgery | If applicable, follow-up and type of lymphedema surgery | baseline to follow up (no later than December 2024) |
| Circumferences of the affected and unaffected side | Circumferences of the affected and unaffected side preoperatively and at postoperative time points. | baseline to follow up (no later than December 2024) |
| Postoperative complications | Postoperative complications | baseline to follow up (no later than December 2024) |
| Surgery duration. | Surgery duration in minutes. | baseline to follow up (no later than December 2024) |
| Type of lymphedema surgery | Type of lymphedema surgery including number of anastomoses, localization, long-term patency. | baseline to follow up (no later than December 2024) |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema | Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema | baseline to follow up (no later than December 2024) |
| Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with lymphedema surgery performed at the University Hospital Basel between 2015 and 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth A Kappos, PD Dr. med | Contact | 0041 61 265 25 25 | elisabeth.kappos@usb.ch | |
| Adriano Fabi, BMed | Contact | 0041 79 888 12 51 | adriano.fabi@uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth A Kappos, PD Dr. med | USB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Date of lymphedema surgery | Date of lymphedema surgery. | baseline to follow up (no later than December 2024) |
| Use of compression stockings | Use of compression stockings | baseline to follow up (no later than December 2024) |
| Number of lymphedema drainages per week | Number of lymphedema drainages per week. | baseline to follow up (no later than December 2024) |
| Stage of lymphedema | Stage of lymphedema (stage I, II or III) | baseline to follow up (no later than December 2024) |
| Duration of lymphedema | Duration of lymphedema. | baseline to follow up (no later than December 2024) |
| Location of lymphedema | Location of lymphedema. | baseline to follow up (no later than December 2024) |
| Subsequent cancer treatment | Subsequent cancer treatment (Chemotherapy, Radiotherapy) | baseline to follow up (no later than December 2024) |
| Date of cancer related surgery | Date of cancer related surgery | baseline to follow up (no later than December 2024) |
| Tumor staging | Tumor staging, considering the following parameters: tumor node metastasis (TNM), resection status of the cancerous growth (R), lymphatic vessel invasion by cancerous cells (L), venous invasion by cancerous cells (V) and grade of cancer cells (G). | baseline to follow up (no later than December 2024) |
| Tumor location | Tumor location (right, left, both sides). | baseline to follow up (no later than December 2024) |
| BMI | Patient's BMI in kg/m2. | baseline to follow up (no later than December 2024) |
| Comorbidities | Existence of comorbidities. | baseline to follow up (no later than December 2024) |
| Age | Patient's age in years. | baseline to follow up (no later than December 2024) |
| Gender | Patient's gender, given the possibilities male or female. | baseline to follow up (no later than December 2024) |
Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer |
| baseline to follow up (no later than December 2024) |
| Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history | Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history | baseline to follow up (no later than December 2024) |
| Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history | Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history | baseline to follow up (no later than December 2024) |
| Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS | Analysis of cohort subgroups: all patients who underwent Deep Inferior Epigastric Perforator (DIEP) flap or Transverse Rectus Abdominis Myocutaneous (TRAM) flap or Latissimus Dorsi Myocutaneous (LDM) flap or implant based breast reconstruction or Breast Conserving Surgery (BCS) | baseline to follow up (no later than December 2024) |
| Analysis of cohort subgroups: exploratory | Analysis of cohort subgroups: exploratory | baseline to follow up (no later than December 2024) |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |