Prevalence of postoperative lymphoedema in gynaecological malignancies
Research type
Research Study
Full title
The prevalence of symptomatic lower limb lymphoedema (LLL) following lymphadenectomy in patients with gynaecological malignancies.
IRAS ID
145823
Contact name
Nicola MacDonald
Contact email
Sponsor organisation
UCLH
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
Lower limb lymphoedema (swelling of the legs) is a significant complication post-lymphaedenectomy surgery in gynaecological cancer patients. Lymphoedema affects patients' vocational, domestic, social and sexual life. It is vitally important that patients undergoing lymphadenectomy for gynaecological cancer treatment should be informed about their risk of postoperative lymphoedema. In the UK, we lack this local data. The aim of this study is to estimate the prevalence of this complication in a NHS cancer treatment centre. Additionally, we aim to evaluate risk factors and to design a clinical model that may help predict patients who are most at risk of postoperative lower limb lymphoedema.
Patients who underwent lymphadenectomy surgery at UCLH between Jan 2005 - Jan 2014, with a diagnosis of gynaecological cancer, over the age of 18 years old, without primary diagnosis of lymphoedema may be eligible for this study. They will be invited by post, which will include an invitation letter, patient information sheet, patient questionnaire and consent forms. Patients will have 3 months to reply. If they do not respond within the first month, they will be sent a second postal invitation; and if there remains no response, no further contacts will be made to inconvenience patients. Patients are asked to complete a validated questionnaire designed to screen for symptomatic lymphoedema. They are asked to return this completed questionnaire with their signed written consent form, in the enclosed pre-paid envelope, back to the UCLH research team, within 3 months. They would be asked to consent for their direct clinical care team to review their medical records, and to collect anonymised medical data. If patient scores 4 or more (screen positive) on their questionnaire, they will be invited by post/telephone to attend UCLH lymphoedema clinic for review. Screen negative patients will receive a letter explaining their results. No funding has been applied.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0123
Date of REC Opinion
31 Mar 2015
REC opinion
Further Information Favourable Opinion