Actively Recruiting
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-10
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
Sana Kliniken Düsseldorf GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how to develop a detailed and practical algorithm to guide surgical treatment for chronic lymphedema that occurs after breast cancer surgery. This observational study aims to fill the current gap in evidence-based recommendations by analyzing data from patients who previously underwent breast cancer-related surgery and later developed lymphedema. The goal is to improve treatment decisions and patient quality of life while supporting insurance coverage approval through stronger scientific data. The study involves reviewing past cases of patients who had chronic lymphedema lasting more than three months and underwent one or more specific surgical procedures for this condition. These procedures include Lymph Node-Vein Anastomosis, Lymphaticovenous Anastomosis, Tumescent Liposuction, Vascularized Lymph Node Transfer, and Water-Assisted Liposuction. Researchers will analyze these surgical treatments and their outcomes to create the "Basel Lymphedema Protocol" as an evidence-based surgical guideline. Participants' data will be collected retrospectively, including details such as surgery dates, type and duration of surgery, lymphedema stage and location, use of compression stockings, and postoperative complications. The study will assess patient characteristics, tumor information, and follow-up results to understand treatment effects better. This comprehensive evaluation will allow researchers to design an integrated algorithm by the end of 2024 and ultimately improve personalized surgical care for chronic lymphedema after breast cancer treatment.
CONDITIONS
Brief Title
An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Status post breast cancer or another type of cancer or no cancer
- Chronic lymphedema lasting over three months before surgery
- Received one or more surgical procedures for chronic lymphedema treatment
- Surgical procedures include Lymph Node-Vein Anastomosis, Lymphaticovenous Anastomosis, Tumescent Liposuction, Vascularized Lymph Node Transfer, and/or Water-Assisted Liposuction
You will not qualify if you...
- Inclusion criteria not met
- Loss to follow-up or data not successfully collected
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies per participant depending on surgery and recovery
Participants who have chronic lymphedema undergo surgical procedures such as Lymph Node-Vein Anastomosis, Lymphaticovenous Anastomosis, Tumescent Liposuction, Vascularized Lymph Node Transfer, and/or Water-Assisted Liposuction, followed by immediate post-operative care.
1 surgery day visit and several immediate post-operative visits
Duration - Up to December 2024 from baseline
Participants are followed up to monitor outcomes including lymphedema status, post-operative complications, and overall recovery to inform the development of the Basel Lymphedema Protocol.
Multiple follow-up visits until December 2024
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
E
Elisabeth A Kappos, PD Dr. med
A
Adriano Fabi, BMed
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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