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.
Study Type
OBSERVATIONAL
Enrollment
500
University Hospital Basel
Basel, Switzerland
RECRUITINGTo 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.
Time frame: baseline to follow up (no later than December 2024)
Date of follow-up procedure
Date of follow-up procedure.
Time frame: 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
Time frame: 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.
Time frame: baseline to follow up (no later than December 2024)
Postoperative complications
Postoperative complications
Time frame: baseline to follow up (no later than December 2024)
Surgery duration.
Surgery duration in minutes.
Time frame: 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.
Time frame: baseline to follow up (no later than December 2024)
Date of lymphedema surgery
Date of lymphedema surgery.
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Time frame: baseline to follow up (no later than December 2024)
Use of compression stockings
Use of compression stockings
Time frame: baseline to follow up (no later than December 2024)
Number of lymphedema drainages per week
Number of lymphedema drainages per week.
Time frame: baseline to follow up (no later than December 2024)
Stage of lymphedema
Stage of lymphedema (stage I, II or III)
Time frame: baseline to follow up (no later than December 2024)
Duration of lymphedema
Duration of lymphedema.
Time frame: baseline to follow up (no later than December 2024)
Location of lymphedema
Location of lymphedema.
Time frame: baseline to follow up (no later than December 2024)
Subsequent cancer treatment
Subsequent cancer treatment (Chemotherapy, Radiotherapy)
Time frame: baseline to follow up (no later than December 2024)
Date of cancer related surgery
Date of cancer related surgery
Time frame: 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).
Time frame: baseline to follow up (no later than December 2024)
Tumor location
Tumor location (right, left, both sides).
Time frame: baseline to follow up (no later than December 2024)
BMI
Patient's BMI in kg/m2.
Time frame: baseline to follow up (no later than December 2024)
Comorbidities
Existence of comorbidities.
Time frame: baseline to follow up (no later than December 2024)
Age
Patient's age in years.
Time frame: baseline to follow up (no later than December 2024)
Gender
Patient's gender, given the possibilities male or female.
Time frame: baseline to follow up (no later than December 2024)
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
Time frame: 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
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: baseline to follow up (no later than December 2024)
Analysis of cohort subgroups: exploratory
Analysis of cohort subgroups: exploratory
Time frame: baseline to follow up (no later than December 2024)