Clinical Research Directory

Lymphoedema and Nocturia/Nocturnal Polyuria After Pelvic LND for Urogenital Cancer

After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and/ or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence/ prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated. Additionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).

Effects of Hydrotherapy on Unilateral Lower Extremity Lymphedema

Lymphedema is a chronic condition that negatively affects patients' quality of life and lower extremity functions, causing swelling and a feeling of heaviness in the extremity, as well as posing an economic burden. The gold standard in lymphedema treatment is complex decongestive therapy.Manual lymphatic drainage, skin care, the use of compression garments, and home exercise programs play an important role. Exercise therapies lead to a reduction in volume and an improvement in functionality and quality of life in patients with lymphedema. However, studies on this subject have mostly focused on upper extremity lymphedema. This study aims to compare the effects of a home exercise program and hydrotherapy combined with a home exercise program on quality of life, lower extremity functionality, exercise capacity, and edema severity in patients with unilateral lower extremity lymphedema

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 4

Research investigating measurement properties for evaluating the decongestive treatment effect on different edema characteristics (e.g. water volume, hardness of the skin, water content,..) at the level of the lower limbs is missing. Information about the clinical relevant change criteria after treatment for nearly all these edema characteristics, is not present and requires investigation. To assess the merits of each treatment in a reproducible manner, a reliable way of measuring limb volume and other edema characteristics must be established, as the evaluation of treatment effects without appropriate tools might lead to biased treatment effects. First of all, in clinical practice, it is of utmost importance to know which edema characteristics need to be evaluated in order to assess the clinical evolution of a patient with lymphedema during and after treatment. Secondly, in order to draw proper conclusions about the treatment effect, it is necessary that to know from which criterion (or cut-off value) one can speak of a real clinical change for a certain lymphedema characteristic. Given that the edema characteristics that are most responsive to treatment and their corresponding criteria for clinically significant and relevant changes at the lower limbs have never been investigated before, the need for this research is high. Therefore, the research questions in this study are: Which measurement tool(s) are able to detect clinically relevant changes in the lymphedema characteristics after the intensive treatment and during the maintenance treatment? When can a clinician speak of a clinically relevant change?

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL). The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.