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

Primary Purpose

Lymphoedema of Leg, Lymphedema Arm, Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Usual care
Reconstructive lymphatic surgery
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoedema of Leg focused on measuring Reconstructive lymphatic surgery, Decongestive lymphatic therapy, Lymphovenous anastomosis, Lymph node transfer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ghent University HospitalRecruiting
  • University Hospitals of Leuven, center for lymphedemaRecruiting
  • CHU-UCL Mont-GodinneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reconstructive lymphatic surgery

No surgery

Arm 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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
General health-related QoL
evaluated with the EuroQol-5D-5L questionnaire
Limb volume
evaluated using circumference measures (ml)
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
The hours of wearing the compression garment during one week
evaluated with the International Compression Club (ICC) questionnaire ('dosage score' between 0-168h)
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)
The physical activity level
evaluated with the International Physical Activity Questionnaire (IPAQ) - short form (MET-hours/week)
The need for intensive treatment due to an increase in lymphoedema volume
through interview
Body weight
measured using a balance
Work capacity
evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
Work ability
evaluated with the Quickscan 18 (short form) questionnaire
Infection during the previous 18 months (yes/no)
through interview
Complications of surgery
through interview
Recurrence of cancer (yes/no)
through medical file
Lymphatic transport
through lymphoscintigraphy
Costs related to lymphoedema and its treatment during previous 18 months
through interview

Full Information

First Posted
August 24, 2021
Last Updated
February 22, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05064176
Brief Title
Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoedema of Leg, Lymphedema Arm, Lymphedema
Keywords
Reconstructive lymphatic surgery, Decongestive lymphatic therapy, Lymphovenous anastomosis, Lymph node transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Given the nature of the trial, blinding of participants, the person who performs the trial assessments (= investigator) and care providers (surgeon/ physical therapist/ compression specialist) is not feasible. The person who will be performing data analyses (= outcome assessor) will be blinded to the participants' randomization.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reconstructive lymphatic surgery
Arm Type
Experimental
Arm 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)
Arm Title
No surgery
Arm Type
Active Comparator
Arm Description
All patients receive usual care (i.e. maintenance decongestive lymphatic therapy)
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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
Procedure
Intervention Name(s)
Reconstructive lymphatic surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
Description
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
Time Frame
at 18 months
Secondary Outcome Measure Information:
Title
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
Description
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
Time Frame
at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months
Title
General health-related QoL
Description
evaluated with the EuroQol-5D-5L questionnaire
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
Limb volume
Description
evaluated using circumference measures (ml)
Time Frame
at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months
Title
Failure to reduce the hours a day of wearing the compression stocking
Description
failure is defined as not able to continue the reduction of the hours of wearing the compression garment as stated by the protocol
Time Frame
at 12, 18, 24, 36 months
Title
The hours of wearing the compression garment during one week
Description
evaluated with the International Compression Club (ICC) questionnaire ('dosage score' between 0-168h)
Time Frame
at 12, 18 (key secondary outcome), 24, 36 months
Title
The experience of the compression garment
Description
evaluated with the International Compression Club (ICC) questionnaire ('comfort score' between 0-10 and 'complication score' between 0-10)
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
The physical activity level
Description
evaluated with the International Physical Activity Questionnaire (IPAQ) - short form (MET-hours/week)
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
The need for intensive treatment due to an increase in lymphoedema volume
Description
through interview
Time Frame
at 6, 12, 18, 24, 36 months
Title
Body weight
Description
measured using a balance
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
Work capacity
Description
evaluated with the Work Productivity and Activity Impairment (WPAI-GH) questionnaire
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
Work ability
Description
evaluated with the Quickscan 18 (short form) questionnaire
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
Infection during the previous 18 months (yes/no)
Description
through interview
Time Frame
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)
Title
Complications of surgery
Description
through interview
Time Frame
at 1, 3, 6, 12, 18, 24, 36 months
Title
Recurrence of cancer (yes/no)
Description
through medical file
Time Frame
at 36 months
Title
Lymphatic transport
Description
through lymphoscintigraphy
Time Frame
at 18 months
Title
Costs related to lymphoedema and its treatment during previous 18 months
Description
through interview
Time Frame
at 18, 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nele Devoogdt
Phone
0032 16 34 25 15
Email
nele.devoogdt@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa De Vrieze
Phone
0032 16 34 50 06
Email
tessa.devrieze@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nele Devoogdt
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Deltombe
Organizational Affiliation
CHU-UCL Mont-Godinne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caren Randon
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University Hospital
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caren Randon, PhD
Email
Caren.randon@uzgent.be
Phone
0032 9 332 34 49
Facility Name
University Hospitals of Leuven, center for lymphedema
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nele Devoogdt, PhD
Phone
0032 16 342515
Email
nele.devoogdt@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Tessa De Vrieze, PhD
Phone
0032 16 34 50 06
Email
tessa.devrieze@kuleuven.be
Facility Name
CHU-UCL Mont-Godinne
City
Namur
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Deltombe, PhD
Email
Thierry.deltombe@uclouvain.be
Phone
0032 81 42 37 72

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data (IPD) can be shared upon request.
Links:
URL
https://kce.fgov.be/en/kce-191245-comparison-of-reconstructive-surgery-versus-no-surgery-additional-to-decongestive
Description
Belgium Health Care Knowledge Centre (KCE)
URL
https://www.caredon.org/
Description
Improving Care for Edema and Oncology patients (CarEdOn)

Learn more about this trial

Added Value of Reconstructive Lymphatic Surgery to Usual Care in Lymphoedema

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