Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema (SurLym)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Lymphedema Arm; Lymphedema; Lymphoedema of Leg

Treatments: Other: Usual care; Procedure: Reconstructive lymphatic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05064176

KCE19-1245

Details and patient eligibility

About

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?'

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral or bilateral, primary or secondary lymphoedema of the upper or lower limb

• If cancer-related lymphoedema, approval for participation in study from oncological specialist (patient participation has to be discussed during Multidisciplinary Oncological Consult); approval if:

  • estimated cancer-related survival is ≥3 years
  • oncological safety is guaranteed: for instance, time interval since radiotherapy/ chemotherapy is ≥3 months

• Lymphoedema stage 1 to 2b

• Objective diagnosis of lymphoedema: ≥ 5% volume difference OR ≥ 2 minor/ 1 major criteria on lymphoscintigraphy OR presence of IndoCyanineGreen (ICG) dermal backflow

• Score on Lymph-ICF questionnaire at screening: ≥ 25 / 100 (= moderate level of problems in functioning related to the development of lymphoedema)

• History of at least 6 months of decongestive lymphatic therapy (DLT) until minimal pitting

• Age ≥ 18 years

Exclusion criteria

• Participants with history of liposuction, lymphovenous anastomosis, lymph node transfer
• Pregnant participants
• Severe obese participants: BMI>35
• Estimated cancer-related survival is <3 years and oncological safety is not guaranteed (e.g. interval since radiotherapy/ chemotherapy is <3 months)
• In case of lower limb lymphoedema: presence of chronic venous insufficiency C4, C5, C6; deep venous thrombosis; post-thrombotic syndrome
• Allergy for ICG, iodine, penicillin and sulphonamides; increased activity of thyroid gland; benign tumour in thyroid; heparin use and severe renal insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Reconstructive lymphatic surgery

Experimental group

Description:

The intervention treatment is reconstructive lymphatic surgery and consists of the application of lymphovenous anastomosis (LVA), lymph node transfer (LNT) or a combination of both. The choice of reconstructive technique(s) is determined by the surgeon and is based on the algorithm for reconstructive lymphatic surgery of lymphoedema. Additionally, all patients receive usual care (i.e. maintenance decongestive lymphatic therapy)

Treatment:

Procedure: Reconstructive lymphatic surgery

Other: Usual care

No surgery

Active Comparator group

Description:

All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)

Treatment:

Other: Usual care