Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00604994

Acronym

LEGS

Enrollment

761

Registered

2008-01-30

Start date

2008-06-30

Completion date

2013-04-30

Last updated

2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Endometrial Cancer, Female Genital Diseases, Ovarian Cancer, Vulval Cancer

Keywords

Lymphoedema, Gynaecology, Oncology, Malignant, Benign, Incidence

Brief summary

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.

Detailed 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: 1. At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment. 2. 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. 3. 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. 4. There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

* Patients with a pacemaker. * Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.

Design outcomes

Primary

Measure	Time frame
Time of onset of lymphoedema after gynaecological cancer treatment.	2 years
Incidence of lymphoedema after gynaecological cancer treatment.	2 years
Point prevalence of lymphoedema after gynaecological cancer treatment.	2 years
Severity of lymphoedema after gynaecological cancer treatment.	2 years

Secondary

Measure	Time frame
Impact of risk factors on development of lymphoedema.	2 years
Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.	2 years
Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.	2 years

Countries

Australia

Outcome results