Compression Stockings for Preventing Lower Limb Lymphedema in Women Treated for Gynecological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Lower Limb Volume (%)
研究概览
简要总结
The goal of this clinical trial was to evaluate whether compression stockings (23-32 mmHg) reduce the incidence of postoperative lymphedema and accompanying symptoms, as well as to assess the comfort of using compression in women undergoing treatment for gynecological malignancies up to one year after surgery.
The main objectives were to determine:
Whether compression stockings applied immediately after radical surgery, in combination with physical activity, reduce the risk of developing lymphedema.
Whether the use of compression stockings affects the quality of life. Whether compression stockings influence specific physical complaints related to the lower limbs.
Patients were assessed preoperatively and at 3, 6, and 12 months postoperatively. Limb circumferences were measured at predefined anatomical points to calculate limb volume changes over time. Additionally, subjective symptoms, quality of life, and adherence to compression therapy were evaluated.
Researchers compared a group using compression stockings with a control group without compression to analyze potential benefits and complications.
详细描述
Background and Rationale Lymphedema is a frequent and debilitating complication following radical surgery for gynecological malignancies. It affects patients' quality of life, contributing to discomfort, impaired mobility, and an increased risk of infections. Despite the widespread use of compression therapy in managing lymphedema, there is limited evidence on its preventive role when applied immediately after surgery.
This study investigates the effectiveness of compression stockings (23-32 mmHg) in reducing the incidence of postoperative lower limb lymphedema and associated symptoms in women undergoing treatment for gynecological cancers. Additionally, it evaluates the impact of compression on patients' quality of life and physical complaints up to one year postoperatively.
A total of 75 eligible women consented to participate and were preoperatively randomized (simple randomization using a random number generator) into two groups:
Compression Group (CG): Patients received individually fitted round-knit compression stockings (23-32 mmHg, RAL-GZG standard) and were instructed to wear them for approximately 9 hours per day.
No Compression Group (NCG): Patients did not receive compression therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Women who underwent radical surgery for vulvar cancer. Women who underwent radical surgery for cervical, uterine, or ovarian cancer, with systemic pelvic lymph node dissection.
- •Overweight or obese patients (BMI > 25.0 kg/m²) treated for uterine or ovarian cancer, regardless of whether systemic pelvic lymph node dissection was performed.
- •Women over 18 years of age.
排除标准
- •Women with a history of lymphedema, venous edema, an ECOG score > 2, congestive heart failure, renal failure, hypothyroidism, leg ulcers, or severe lower limb ischemia (Fontaine class ≥ 2), as well as those with metastases, relapse, or other malignancies treated within five years prior to study entry, were excluded.
结局指标
主要结局
Change in Lower Limb Volume (%)
时间窗: Measurements were taken preoperatively and at 3, 6, and 12 months postoperatively
Lower limb volume change (%) was calculated based on circumferential measurements taken every 4 cm along the limb, using the truncated cone formula. . The percentage change was calculated relative to preoperative limb volume. Unit of Measure: Percentage (%)
次要结局
- Presence of Lymphedema(were noted before and after 3, 6 and 12 months after surgery)
- Relative Edema Size (%)(were taken before and after 3, 6 and 12 months after surgery i)
- Weight-Adjusted Volume Change (WAC) (%)(were taken before and after 3, 6 and 12 months after surgery)
研究者
Joanna Kurpiewska-Pieniążek
Principal Investigator, PhD
Andrzej Frycz Modrzewski Krakow University