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Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

18 Years
Not Enrolling
Female Genital Diseases, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Vulval Cancer

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Trial Information

Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

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

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.

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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Time of onset of lymphoedema after gynaecological cancer treatment.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Andreas Obermair, MD FRANZCOG CGO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queensland Centre for Gynaecological Cancer


Australia: National Health and Medical Research Council

Study ID:




Start Date:

June 2008

Completion Date:

April 2013

Related Keywords:

  • Female Genital Diseases
  • Ovarian Cancer
  • Cervical Cancer
  • Endometrial Cancer
  • Vulval Cancer
  • Lymphoedema
  • Gynaecology
  • Oncology
  • Malignant
  • Benign
  • Incidence
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Genital Diseases, Female
  • Lymphedema
  • Ovarian Neoplasms
  • Vulvar Neoplasms
  • Adenoma