Abstract
Background: The Lymphoedema Evaluation in Gynecological cancer Study (LEGS) was a longitudinal, observational, cohort study prospectively evaluating the incidence and risk factors of lower-limb lymphedema after treatment for gynecological cancer. Here we describe the study protocol and characteristics of the sample. Methods: Women with a newly diagnosed gynecological cancer between June 1, 2008 and February 28, 2011, aged 18 years or older, and treated at one of six hospitals in Queensland, Australia, were eligible. Lymphedema was assessed by circumference measurements, bioimpedance spectroscopy, and self-reported swelling. LEGS incorporated a cohort of patients requiring surgery for benign gynecological conditions for comparison purposes. Data were collected prior to surgery and at regular intervals thereafter up to 2-years post-diagnosis. Results: 546 women participated (408 cancer, 138 benign), with a 24-month retention rate of 78%. Clinical and treatment characteristics of participants were similar to the Queensland gynecological cancer population, except for a higher proportion of early-stage cervical cancers recruited to LEGS compared with Queensland proportions (89% versus 55%, respectively). Discussion: Few imbalances were observed between participants with complete and incomplete follow-up data. The prospective design and collection of objective and patient-reported outcome data will allow comprehensive assessment of incidence and risk factors of lower-limb lymphedema.
Highlights
The lymphatic vascular system complements the venous and arterial vessel systems in the body
The purpose of this paper is to provide a detailed report of the Lymphoedema Evaluation in Gynecological cancer Study (LEGS) study protocol, to describe the characteristics of the sample and to evaluate sample generalizability to the wider gynecological cancer cohort
Cancer treatment for gynecological cancer in Queensland is largely centralized with all gynecological oncologists working together within the Queensland Centre for Gynecological Cancer (QCGC) including both public and private hospitals
Summary
The lymphatic vascular system complements the venous and arterial vessel systems in the body. It drains and transports fluids, proteins and immunecompetent cells (lymphocytes). Defects in the lymphatic system can lead to primary (congenital) lymphoedema or secondary (acquired) lymphoedema. Primary lymphoedema accounts for 10% of all lymphoedema patients [1]. Secondary lymphoedema (LE) is most recognizably associated with parasite infection in developing countries, and following treatment for cancer in developed countries. Secondary LE after cancer is thought to be caused through removal of lymph nodes and damage to lymph vessels during treatment (surgery, radiotherapy) resulting in reduced flow or stasis of lymph fluid. We describe the study protocol and characteristics of the sample
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