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Reduction of Arm Volume and Improvement in Lymphedema Via Surgery

NCT06606145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2024-09-20

No results posted yet for this study

Summary

This clinical trial aims to evaluate the effectiveness of lymphatic microsurgical treatments in reducing limb volume in female patients with breast cancer-related lymphedema (BCRL).

The study focuses on three treatments: Lymphovenous Anastomosis (LVA), Vascularized Lymph Node Transfer (VLNT), and Complex Decongestive Therapy (CDT).

The main questions it aims to answer are:

* Can LVA, VLNT, or their combination significantly reduce limb volume in patients with BCRL?
* How does the effectiveness of these surgical interventions compare to CDT alone?

Researchers will compare patients who undergo LVA, VLNT, or a combination of both to those receiving only CDT to determine the effectiveness of surgical interventions in reducing lymphedema symptoms.

Participants will:

* Undergo pre- and post-operative limb volume measurements.
* Receive either LVA, VLNT, or combined LVA and VLNT surgery, or continue CDT alone.
* Be monitored for one year to assess changes in limb volume and quality of life.

Conditions

  • Lymphedema
  • Lymphedema Arm
  • Lymphedema of Arm
  • Lymphedema of Upper Limb
  • Lymphedema, Secondary

Interventions

PROCEDURE

Lymphovenous Anastomosis

LVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage.

PROCEDURE

Vascularized Lymph Node Transfer

VLNT involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis.

PROCEDURE

Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer

Combined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb.

PROCEDURE

Complex Decongestive Therapy

The current standard of care for most BRCL patients includes conservative measures known as Complex Decongestive Therapy (CDT), consisting of compression therapy with low-stretch bandages, manual lymphatic drainage, exercise, and skincare.

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2019-12-31
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606145 on ClinicalTrials.gov