Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
NCT ID: NCT00604994
Last Updated: 2013-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
761 participants
OBSERVATIONAL
2008-06-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Malignant
Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina
No interventions assigned to this group
Benign
Patients without malignant gynaecological cancers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
18 Years
FEMALE
No
Sponsors
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The University of Queensland
OTHER
Royal Brisbane and Women's Hospital
OTHER_GOV
Mater
OTHER
Mater Private Hospital
OTHER
Queensland Institute of Medical Research
OTHER
Queensland University of Technology
OTHER
Australia New Zealand Gynaecological Oncology Group
OTHER
Cancer Australia
OTHER
Queensland Centre for Gynaecological Cancer
OTHER_GOV
Responsible Party
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Principal Investigators
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Andreas Obermair, MD FRANZCOG CGO
Role: PRINCIPAL_INVESTIGATOR
Queensland Centre for Gynaecological Cancer
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Health Services
South Brisbane, Queensland, Australia
Royal Women's Hospital
Carlton, Victoria, Australia
Countries
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Related Links
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QCGC Research
Other Identifiers
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LEGS
Identifier Type: -
Identifier Source: org_study_id