Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 761
- 试验地点
- 6
- 主要终点
- Time of onset of lymphoedema after gynaecological cancer treatment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients with a pacemaker.
- •Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
结局指标
主要结局
Time of onset of lymphoedema after gynaecological cancer treatment.
时间窗: 2 years
Incidence of lymphoedema after gynaecological cancer treatment.
时间窗: 2 years
Point prevalence of lymphoedema after gynaecological cancer treatment.
时间窗: 2 years
Severity of lymphoedema after gynaecological cancer treatment.
时间窗: 2 years
次要结局
- 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)