Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

NCT ID: NCT05064176

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2026-12-31

Brief 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?'

Detailed 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.

Conditions

Lymphoedema of Leg; Lymphedema Arm; Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reconstructive lymphatic surgery

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)

Group Type: EXPERIMENTAL

Usual care

Intervention Type: OTHER

Home physical therapist performs usual care and educates the patient to perform self-management

Usual care:

M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):

• week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group)
• week 3-4: start physical therapy, 2 days/ week: exercises, skin care & manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care & MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions)

M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:

• 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up

Reconstructive lymphatic surgery

Intervention Type: PROCEDURE

For the procedure of LVA:

• Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly

For the procedure of LNT:

• Aim:

1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;

2. Placed lymph nodes induce lymphangiogenesis

No surgery

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Home physical therapist performs usual care and educates the patient to perform self-management

Usual care:

M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):

• week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group)
• week 3-4: start physical therapy, 2 days/ week: exercises, skin care & manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care & MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions)

M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:

• 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up

Interventions

Usual care

Home physical therapist performs usual care and educates the patient to perform self-management

Usual care:

M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):

• week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group)
• week 3-4: start physical therapy, 2 days/ week: exercises, skin care & manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care & MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions)

M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:

• 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up

Intervention Type: OTHER

Reconstructive lymphatic surgery

For the procedure of LVA:

• Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly

For the procedure of LNT:

• Aim:

1. Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;

2. Placed lymph nodes induce lymphangiogenesis

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nele Devoogdt

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Thierry Deltombe

Role: PRINCIPAL_INVESTIGATOR

CHU-UCL Mont-Godinne

Caren Randon

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Site Status: RECRUITING

University Hospitals of Leuven, center for lymphedema

Leuven, , Belgium

Site Status: RECRUITING

CHU-UCL Mont-Godinne

Namur, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Nele Devoogdt

Role: CONTACT

nele.devoogdt@kuleuven.be

0032 16 34 25 15

Tessa De Vrieze

Role: CONTACT

tessa.devrieze@kuleuven.be

0032 16 34 50 06

Facility Contacts

Caren Randon, PhD

Role: primary

Caren.randon@uzgent.be

Role: backup

0032 9 332 34 49

Nele Devoogdt, PhD

Role: primary

nele.devoogdt@uzleuven.be

0032 16 342515

Tessa De Vrieze, PhD

Role: backup

tessa.devrieze@kuleuven.be

0032 16 34 50 06

Thierry Deltombe, PhD

Role: primary

Thierry.deltombe@uclouvain.be

Role: backup

0032 81 42 37 72

References

Devoogdt N, De Vrieze T, Heroes AK, Bechter-Hugl B, Fieuws S, Godderis L, Segers K, Maleux G, Deltombe T, Frippiat J, Servaes M, Berners A, Fosseprez P, Krug B, Kayser F, Falticeanu A, Randon C, Monten C, Van Landuyt K, De Pypere B, Degraeve L, Decorte T, De Schryver M, Van Besien V, Devos D, Suominen S, Ayala JM, Pons G, Fourneau I, Thomis S. SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema. BMJ Open. 2024 May 10;14(5):e078114. doi: 10.1136/bmjopen-2023-078114.

Reference Type: DERIVED

PMID: 38729754 (View on PubMed)

Related Links

https://kce.fgov.be/en/kce-191245-comparison-of-reconstructive-surgery-versus-no-surgery-additional-to-decongestive

Belgium Health Care Knowledge Centre (KCE)

https://www.caredon.org/

Improving Care for Edema and Oncology patients (CarEdOn)

Other Identifiers

KCE19-1245

Identifier Type: -

Identifier Source: org_study_id