Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

Lymphedema Clinical Trial

— SurLym  

Official title:

Comparison of Reconstructive Lymphatic Surgery Versus no Surgery, Additional to Decongestive Lymphatic Therapy (Usual Care), for the Treatment of Iymphoedema, Through a Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05064176
• Other study ID #: KCE19-1245
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 2026

Study information

• Verified date: February 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Nele Devoogdt
• Phone: 0032 16 34 25 15
• Email: nele.devoogdt[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

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?'

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema Arm
• Lymphoedema of Leg

Intervention

Other:
• 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

Procedure:
• 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: Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network; Placed lymph nodes induce lymphangiogenesis

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Gent
Belgium	University Hospitals of Leuven, center for lymphedema	Leuven
Belgium	CHU-UCL Mont-Godinne	Namur

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)	evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema	at 18 months
Secondary	Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)	evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema	at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
Secondary	General health-related QoL	evaluated with the EuroQol-5D-5L questionnaire	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	Limb volume	evaluated using circumference measures (ml)	at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
Secondary	Failure to reduce the hours a day of wearing the compression stocking	failure is defined as not able to continue the reduction of the hours of wearing the compression garment as stated by the protocol	at 12, 18, 24, 36 months
Secondary	The hours of wearing the compression garment during one week	evaluated with the International Compression Club (ICC) questionnaire ('dosage score' between 0-168h)	at 12, 18 (key secondary outcome), 24, 36 months
Secondary	The experience of the compression garment	evaluated with the International Compression Club (ICC) questionnaire ('comfort score' between 0-10 and 'complication score' between 0-10)	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	The physical activity level	evaluated with the International Physical Activity Questionnaire (IPAQ) - short form (MET-hours/week)	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	The need for intensive treatment due to an increase in lymphoedema volume	through interview	at 6, 12, 18, 24, 36 months
Secondary	Body weight	measured using a balance	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	Work capacity	evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	Work ability	evaluated with the Quickscan 18 (short form) questionnaire	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	Infection during the previous 18 months (yes/no)	through interview	at 18, 36 months (adverse events are collected during each clinical assessment but the amount of infections as secondary outcome are taken together for statistical analyses per 18 months)
Secondary	Complications of surgery	through interview	at 1, 3, 6, 12, 18, 24, 36 months
Secondary	Recurrence of cancer (yes/no)	through medical file	at 36 months
Secondary	Lymphatic transport	through lymphoscintigraphy	at 18 months
Secondary	Costs related to lymphoedema and its treatment during previous 18 months	through interview	at 18, 36 months

External Links

•   Belgium Health Care Knowledge Centre (KCE)
•   Improving Care for Edema and Oncology patients (CarEdOn)