An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol

NCT ID: NCT06374745

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-02

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphedema Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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)

* loss to follow-up (data not successfully collected)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sana Kliniken Düsseldorf GmbH

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth A Kappos, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

USB

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Elisabeth A Kappos, PD Dr. med

Role: CONTACT

0041 61 265 25 25

Adriano Fabi, BMed

Role: CONTACT

0041 79 888 12 51

Facility Contacts

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Elisabeth A Kappos, PD Dr. med.

Role: primary

0041 61 265 25 25

Adriano Fabi, BMed

Role: backup

0041 79 888 12 51

Other Identifiers

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2020-01307; mu24Kappos

Identifier Type: -

Identifier Source: org_study_id

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