Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer (LEGS)

Queensland Centre for Gynaecological Cancer

Status

Completed

Conditions

Female Genital Diseases

Endometrial Cancer

Vulval Cancer

Ovarian Cancer

Cervical Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT00604994

LEGS

Details and patient eligibility

About

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

Full description

Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.

The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.

The following hypotheses will be tested to address the aims of the project:

At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual & financial well-being, compared to those who do not develop lymphoedema.
There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Enrollment

761 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient.
Non-pregnant female patients.
Over 18 years of age at time of surgery.
Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
Patients who are capable of, and have given, informed consent to their participation in the study.

Exclusion criteria