Projects
BARILIP: BARiatric surgery In patients with LIPoedema
BARILIP is a prospective monocentric cohort study examining the influence of obesity surgery on patients with lipoedema and obesity. The study was set up after having found a clinically relevant leg volume reductions in patients with lipoedema and obesity following bariatric surgery in a retrospective trial. The main limitation of that trial was a missing evaluation for pain. The primary endpoint of the BARILIP study is leg volume 24 months after patients have received bariatric surgery. Secondary endpoints are pain score, quality of life and necessity to wear compression garments. It is planned to include 25 patients with confirmed lipoedema and a BMI of > 35 kg/m2. Recruitment and Follow-up Center for this study is the European center for Lymphoedema (Földi Clinic) in Hinterzarten, Germany. Bariatric operations could potentially be performed worldwide. Estimated start of inclusion is August 2022. For further information, please contact jodok.fink@uniklinik-freiburg.de
Lipoedema and women
Lipoedema is a chronic disease that is present in some women. These women have an overproduction of adipose tissue that causes accumulation of fat under the skin.
According to the International Consensus Document about the evaluation and treatment of lipoedema has a woman with lipoedema the following characteristics: 1) unequal distribution of fat tissue over the body, 2) presence of pain in the region with fat accumulation, 3) other problems as heaviness and overweight, 4) functional problems (difficulty to walk), 5) often low self-esteem and 6) often mental problems. The characteristics of patients with lipoedema have not yet been investigated through standardized and objective measurement methods and have never been compared with the characteristics of patients with similar BMI without the diagnosis of lipoedema.
Moreover, some patients with lipoedema undergo liposuction of the excess adipose tissue to reduce the pain symptoms and functional consequences of the lipoedema. A clinical study investigating the effect of a liposuction has not been performed yet.
Therefore, the primary objective of this study is to identify the characteristics of patients with lipoedema and compare them with a BMI-matched population of (obese) patients without lipoedema. This will allow us to develop a clinical evaluation set for patients with lipoedema and set the first steps toward a patient-tailored treatment. A secondary objective is to use the evaluation set to collect pilot data for an efficacy study about liposuction in patients with lipoedema.
To investigate the primary objective, we will include 100 patients with lipoedema and 50 BMI-matched subjects without lipoedema and will evaluate: problems in functioning (with Lymph-ICF-LL questionnaire, adapted for pts with lipoedema), body composition (with BMI, %FM & %FFM, WHR, ratio waist-leg), pain (with NRS, pressure pain thresholds, Brief Pain Inventory and DN4), strength (with Jamar, Wall Sitt test and Biodex), cardiovascular endurance (6MWT), functional mobility (with Timed Up and Go test), physical activity level (with IPAQ) and psychosocial functioning (with Pain Catastrophizing scale, DASS, body image scale, self-efficacy questionnaire and Eating Disorder Examination Questionnaire)
To investigate the secondary objective, we will evaluate 10 patients with lipoedema before and 3 months after the liposuction.
Expected start of inclusion: April 2022
Expected end date: April 2023