Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malignant<br>Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina | |
| Benign<br>Patients without malignant gynaecological cancers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer. |  | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoedema, Gynaecology, Oncology, Malignant, Benign, Incidence