-
Medical and health sciences
- Vascular diseases
- Gynaecology
- Gynaecological surgery
Gynolymph = Trial to inventory the incidence of early and advanced stage lower
limb lymphedema in patients treated for gynaecologic
cancer (started in 2021 and sponsored by “kom op tegen Kanker” till 2025)
Four hundred patients with diagnosis stage 1-3 gynaecologic cancer are
included in an observational cohort between diagnosis until maximum 2 weeks
after start of the first treatment. They will be followed for occurrence of lower
limb lymphedema up till 2 years after their last treatment.
Data on signs and symptoms, quality of life, time investment and financial
expenses will be collected, to provide information on the incidence and risk
factors for lower limb lymphedema, and on its impact on patients, regarding
quality of life, sexual well-being and time- and financial investment.
Patients developing early stage LLL enter an interventional sub-cohort, in which
the effect of class II compressive garments on preventing evolution towards
advanced stage LLL will be evaluated.
To detect a difference, in the interventional sub-cohort 109 subjects are required
per group to have at least 80% power. To correct for drop out we planned to include 400 patients.
As attaining now the planned recruitment period of 24 months and the recruitment number is still not reached, we want to prolong the recruitment period and need budget