Developing a treatment protocol for chronic lymphedema after breast cancer surgery
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
This study is trying to create a clear treatment plan for managing chronic lymphedema after breast cancer surgery to help improve patients' lives and make it easier for them to get insurance coverage for the care they need.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06374745 on ClinicalTrials.gov |
What this trial studies
This study aims to create an integrated algorithm for the surgical treatment of chronic lymphedema that develops after breast cancer surgery. By retrospectively analyzing data from patients who underwent breast cancer-related surgeries, the researchers intend to establish evidence-based recommendations for managing lymphedema. The goal is to provide surgeons with a reliable protocol, known as 'The Basel Lymphedema Protocol', to improve patient outcomes and quality of life. This protocol will also support patients in obtaining insurance coverage for necessary surgical treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals who have chronic lymphedema lasting over three months following breast cancer surgery.
Not a fit: Patients who do not have chronic lymphedema or those who have not undergone relevant surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical treatment options and better quality of life for patients suffering from chronic lymphedema.
How similar studies have performed: While there is limited literature on this specific approach, the study aims to fill a significant gap in evidence-based treatment for lymphedema, suggesting a novel and potentially impactful methodology.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Elisabeth A Kappos, PD Dr. med — Usb
- Study coordinator: Elisabeth A Kappos, PD Dr. med
- Email: elisabeth.kappos@usb.ch
- Phone: 0041 61 265 25 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.