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

Recruiting

• Conditions: Lymphedema; Breast Cancer

• Registration Number: NCT06374745
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2015-01-02
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of compression stockings	baseline to follow up (no later than December 2024)	Use of compression stockings
Comorbidities	baseline to follow up (no later than December 2024)	Existence of comorbidities.
Tumor location	baseline to follow up (no later than December 2024)	Tumor location (right, left, both sides).
Follow-up and type of lymphedema surgery	baseline to follow up (no later than December 2024)	If applicable, follow-up and type of lymphedema surgery
To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery.	baseline to follow up (no later than December 2024)	To design an integrated algorithm for surgical treatment of chronic cancer-associated lymphedema using the following variables captured in Primary Outcomes 2 to 21.
Date of follow-up procedure	baseline to follow up (no later than December 2024)	Date of follow-up procedure.
Postoperative complications	baseline to follow up (no later than December 2024)	Postoperative complications
Type of lymphedema surgery	baseline to follow up (no later than December 2024)	Type of lymphedema surgery including number of anastomoses, localization, long-term patency.
Date of lymphedema surgery	baseline to follow up (no later than December 2024)	Date of lymphedema surgery.
Number of lymphedema drainages per week	baseline to follow up (no later than December 2024)	Number of lymphedema drainages per week.
Stage of lymphedema	baseline to follow up (no later than December 2024)	Stage of lymphedema (stage I, II or III)
Date of cancer related surgery	baseline to follow up (no later than December 2024)	Date of cancer related surgery
Location of lymphedema	baseline to follow up (no later than December 2024)	Location of lymphedema.
Surgery duration.	baseline to follow up (no later than December 2024)	Surgery duration in minutes.
Duration of lymphedema	baseline to follow up (no later than December 2024)	Duration of lymphedema.
BMI	baseline to follow up (no later than December 2024)	Patient's BMI in kg/m2.
Age	baseline to follow up (no later than December 2024)	Patient's age in years.
Circumferences of the affected and unaffected side	baseline to follow up (no later than December 2024)	Circumferences of the affected and unaffected side preoperatively and at postoperative time points.
Tumor staging	baseline to follow up (no later than December 2024)	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).
Gender	baseline to follow up (no later than December 2024)	Patient's gender, given the possibilities male or female.
Subsequent cancer treatment	baseline to follow up (no later than December 2024)	Subsequent cancer treatment (Chemotherapy, Radiotherapy)

Secondary Outcome Measures

Name	Time	Method
Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS	baseline to follow up (no later than December 2024)	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)
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 any kind of cancer prior to their lymphedema
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 who had no history of cancer and thus no cancer-related surgery in their medical 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 with chronic lymphedema regardless of whether or not they have an oncological history
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 surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer
Analysis of cohort subgroups: exploratory	baseline to follow up (no later than December 2024)	Analysis of cohort subgroups: exploratory

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland