Clinical Trials Logo

Clinical Trial Summary

The primary objective of this research proposal is to investigate - in patients with lymphoedema of the upper limb or lower limb (P) - the added value of reconstructive lymphatic surgery (I) - to the decongestive lymphatic therapy (usual care) (C) - on the lymphoedema-specific quality of life (QoL) (O) - at 18 months post-surgery/ no surgery (T) Consequently, a multicentre pragmatic randomised controlled trial is performed to give an answer on following research question: 'Is, in addition to usual care - i.e. decongestive lymphatic therapy -, reconstructive lymphatic surgery (intervention group) superior to no surgery (control group), for the treatment of upper or lower limb lymphoedema?'


Clinical Trial Description

Lymphoedema is a chronic and often debilitating condition caused by lymphatic insufficiency. It leads to swelling of the limb and an increased risk of infection. It can be classified as primary (congenital) or secondary (acquired) lymphoedema. Lymphoedema is very burdensome for the patient and therefore is it often associated with mental problems for example frustration and stress. In addition, because of the increase in volume of the limb, patients also develop physical problems, such as pain, heaviness, loss of strength, and develop functional problems, such as problems with household, mobility or social activities. These mental, physical and functional problems all have a negative impact on quality of life and have an influence on the ability to work. Consensus exist that the first choice of treatment is a conservative treatment. This conservative treatment consists of skin care, compression therapy (i.e. multilayer bandaging and compression garments), exercises and lymph drainage. Reconstructive lymphatic surgery is another option, also often performed: i.e. lymphovenous anastomoses, on the one hand, and a lymph node transfer, on the other hand. By (partially) restoring the lymphatic transport, the reconstructive lymphatic surgery may possibly lead to a larger decrease of the lymphoedema volume and therefore greater discontinuation of the compression garment. Consequently, patients will have an improvement in functioning and quality of life. Currently, scientific evidence for reconstructive lymphatic surgery for the treatment of lymphoedema is missing. Therefore, the aim of this trial is to investigate the added value of reconstructive lymphatic surgery of the lymphatic system in addition to the conservative treatment, for the treatment of lymphoedema. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05064176
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact Nele Devoogdt
Phone 0032 16 34 25 15
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date December 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT02506530 - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Recruiting NCT01318785 - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications Phase 2
Active, not recruiting NCT02308488 - Study of Prone Accelerated Breast And Nodal IMRT Phase 1/Phase 2
Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
Completed NCT00743314 - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer Early Phase 1
Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A
Recruiting NCT04606511 - Lymphedema Screening N/A
Completed NCT04785599 - Lymphedema Prevention After Lymph Node Emptying N/A
Recruiting NCT04606030 - LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) N/A
Active, not recruiting NCT02592213 - Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer Phase 1/Phase 2
Enrolling by invitation NCT02550951 - Utility of MR Lymphangiography in Postoperative Follow-up of Lymphedema: Comparison With Lymphoscintigraphy N/A
Completed NCT02187289 - Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects N/A
Recruiting NCT01954654 - Effectiveness of Accelerated Intervention With Compression Sleeve in Mild and Moderate Breast Cancer-related Lymphedema N/A