Clinical trial NCT06374745: An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
Official title: An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Breast Cancer
Keywords: Post-surgical Treatment
Chronic Lymphedema Treatment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Sana Kliniken Düsseldorf GmbH
First posted: 2024-04-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lymphedema surgery performed at the University Hospital Basel between 2015 and 2023.

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 personalized/precision medicine - treatment tailored to the unique patient - and by so doing, refine resource allocation and cost-effectiveness of the healthcare system.

Eligibility criteria: Inclusion Criteria:

* status post breast cancer or status post another type of cancer or status post no cancer
* chronic lymphedema - lymphedema lasting over three months - present prior to surgical treatment
* one type of surgical procedure for treatment of chronic lymphedema or a combination of surgical procedures for treatment of chronic lymphedema was performed
* one or any combination of the following surgical procedures was used in each individual patient: Lymph Node-Vein Anastomosis (LNVA) , Lymphaticovenous Anastomosis (LVA), Tumescent Liposuction (TL), Vascularized Lymph Node Transfer (VLNT) and/or Water-Assisted Liposuction (WAL)

Exclusion Criteria:

* inclusion criteria not met
* loss to follow-up (data not successfully collected)

Primary outcomes:
measure: To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery.
timeFrame: baseline to follow up (no later than December 2024)
measure: Date of follow-up procedure
timeFrame: baseline to follow up (no later than December 2024)
measure: Follow-up and type of lymphedema surgery
timeFrame: baseline to follow up (no later than December 2024)
measure: Circumferences of the affected and unaffected side
timeFrame: baseline to follow up (no later than December 2024)
measure: Postoperative complications
timeFrame: baseline to follow up (no later than December 2024)
measure: Surgery duration.
timeFrame: baseline to follow up (no later than December 2024)
measure: Type of lymphedema surgery
timeFrame: baseline to follow up (no later than December 2024)
measure: Date of lymphedema surgery
timeFrame: baseline to follow up (no later than December 2024)
measure: Use of compression stockings
timeFrame: baseline to follow up (no later than December 2024)
measure: Number of lymphedema drainages per week
timeFrame: baseline to follow up (no later than December 2024)
measure: Stage of lymphedema
timeFrame: baseline to follow up (no later than December 2024)
measure: Duration of lymphedema
timeFrame: baseline to follow up (no later than December 2024)
measure: Location of lymphedema
timeFrame: baseline to follow up (no later than December 2024)
measure: Subsequent cancer treatment
timeFrame: baseline to follow up (no later than December 2024)
measure: Date of cancer related surgery
timeFrame: baseline to follow up (no later than December 2024)
measure: Tumor staging
timeFrame: baseline to follow up (no later than December 2024)
measure: Tumor location
timeFrame: baseline to follow up (no later than December 2024)
measure: BMI
timeFrame: baseline to follow up (no later than December 2024)
measure: Comorbidities
timeFrame: baseline to follow up (no later than December 2024)
measure: Age
timeFrame: baseline to follow up (no later than December 2024)
measure: Gender
timeFrame: baseline to follow up (no later than December 2024)
Secondary outcomes:
measure: Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema
timeFrame: baseline to follow up (no later than December 2024)
measure: 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
timeFrame: baseline to follow up (no later than December 2024)
measure: Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history
timeFrame: baseline to follow up (no later than December 2024)
measure: Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history
timeFrame: baseline to follow up (no later than December 2024)
measure: Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS
timeFrame: baseline to follow up (no later than December 2024)
measure: Analysis of cohort subgroups: exploratory
timeFrame: baseline to follow up (no later than December 2024)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: USB
name: Elisabeth A Kappos, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: