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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 5
- 主要终点
- Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
研究概览
简要总结
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?'
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)
时间窗: at 18 months
evaluated with the Dutch or French version of the Lymph-ICF questionnaire for upper or lower limb lymphoedema
次要结局
- Lymphoedema-specific QoL (or problems in functioning related to development of lymphoedema)(at 1, 3, 6, 12 (short term) and 24, 36 (longer term) months)
- The experience of the compression garment(at 1, 3, 6, 12, 18, 24, 36 months)
- General health-related QoL(at 1, 3, 6, 12, 18, 24, 36 months)
- Limb volume(at 1, 3, 6, 12, 18 (key secondary outcome), 24, 36 months)
- Failure to reduce the hours a day of wearing the compression stocking(at 12, 18, 24, 36 months)
- The hours of wearing the compression garment during one week(at 12, 18 (key secondary outcome), 24, 36 months)
- The physical activity level(at 1, 3, 6, 12, 18, 24, 36 months)
- Body weight(at 1, 3, 6, 12, 18, 24, 36 months)
- Complications of surgery(at 1, 3, 6, 12, 18, 24, 36 months)
- Recurrence of cancer (yes/no)(at 36 months)
- Lymphatic transport(at 18 months)
- Costs related to lymphoedema and its treatment during previous 18 months(at 18, 36 months)
- The need for intensive treatment due to an increase in lymphoedema volume(at 6, 12, 18, 24, 36 months)
- Work capacity(at 1, 3, 6, 12, 18, 24, 36 months)
- Work ability(at 1, 3, 6, 12, 18, 24, 36 months)
- Infection during the previous 18 months (yes/no)(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))