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Recruiting Observational

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

NCT06374745 · tracked via the Priya Life Science Switzerland tracker
Phase
Observational
Started
2015-01-02
Last updated
2025-02-10

Condition(s) studied

LymphedemaBreast Cancer

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.
  • 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
  • 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.
  • Postoperative complications — baseline to follow up (no later than December 2024)
    Postoperative complications
  • Surgery duration. — baseline to follow up (no later than December 2024)
    Surgery duration in minutes.
  • 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.
  • Use of compression stockings — baseline to follow up (no later than December 2024)
    Use of compression stockings
  • 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)
  • Duration of lymphedema — baseline to follow up (no later than December 2024)
    Duration of lymphedema.
  • Location of lymphedema — baseline to follow up (no later than December 2024)
    Location of lymphedema.
  • Subsequent cancer treatment — baseline to follow up (no later than December 2024)
    Subsequent cancer treatment (Chemotherapy, Radiotherapy)
  • Date of cancer related surgery — baseline to follow up (no later than December 2024)
    Date of cancer related surgery
  • 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).
  • Tumor location — baseline to follow up (no later than December 2024)
    Tumor location (right, left, both sides).
  • BMI — baseline to follow up (no later than December 2024)
    Patient's BMI in kg/m2.
  • Comorbidities — baseline to follow up (no later than December 2024)
    Existence of comorbidities.
  • Age — baseline to follow up (no later than December 2024)
    Patient's age in years.
  • Gender — baseline to follow up (no later than December 2024)
    Patient's gender, given the possibilities male or female.

Trial sites (1)

FacilityCityRegionStatus
University Hospital Basel Basel Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06374745 on ClinicalTrials.gov ↗ ← All trials in Switzerland