Lower Extremity Lymphedema After Gynecologic Cancer Surgery
Conditions
Keywords
Gynecologic Cancer Surgery, Lower Extremity Lymphedema, BMI Stratified Management, Meridian-Lymph Axis Theory
Brief summary
This study aims to investigate the impact of a BMI-stratified intervention program based on the meridian-lymphatic axis theory on the incidence of lower extremity lymphedema in postoperative patients with gynecological malignant tumors at 1 month, 3 months, and 6 months, and to validate the precision and effectiveness of this program compared to traditional CDT. Primary objectives: to evaluate the effects of this program on reducing the incidence of lymphedema, alleviating lymphedema-related symptoms (assessed via GCLQ score), improving patients' quality of life (assessed via LLQoL score), and enhancing patients' self-management behaviors.
Interventions
OTHERMeridian-Lymph Axis Based BMI Stratified Management
Personalized interventions including meridian point stimulation, manual lymphatic drainage, and pressure care, stratified by participant BMI.
OTHERRoutine Lymphatic Edema Care
Standard care including compression garment use, limb elevation, and basic exercise guidance.
Sponsors
Hong Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Female patients aged 18-75 years who have undergone gynecologic cancer surgery (including hysterectomy, oophorectomy, or lymphadenectomy). Diagnosed with lower extremity lymphedema (stage I-II) within 6 months to 2 years post-surgery, confirmed by circumferential measurement. BMI between 18.5 and 35.0 kg/m². Able to understand and sign the informed consent form, and comply with the intervention and follow-up schedule. No history of severe cardiovascular, renal, or hepatic dysfunction that would interfere with study participation. \-
Exclusion criteria
Patients with lower extremity lymphedema caused by other etiologies (e.g., trauma, infection, or congenital lymphedema). History of lower extremity surgery or fracture within 3 months prior to enrollment. Active infection or skin ulceration in the affected lower extremity. Participation in other clinical trials involving lymphedema interventions within the past 3 months. Pregnancy or lactation during the study period. Inability to complete the intervention or follow-up due to cognitive or mobility impairment. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Extremity Lymphedema Volume (Measured by Circumferential Method) | Baseline (before intervention), 12 weeks after intervention initiation | Limb volume change will be calculated using circumferential measurements of the lower extremity (ankle, calf, thigh) to quantify the reduction in lymphedema severity after intervention. |
| Change in Lower Extremity Lymphedema Volume (measured by circumferential measurement) from baseline to 12 weeks after intervention | Baseline, 12 weeks | Limb volume change will be calculated using circumferential measurements of the lower extremity to assess the efficacy of the intervention in reducing lymphedema. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Limb Function Score (using the Lymphoedema Functioning, Disability and Health Questionnaire, LYMPH-Q) from baseline to 12 weeks | baseline to 12 weeks |
| Change in Quality of Life Score (using the European Organization for Research and Treatment of Cancer QLQ-C30) from baseline to 12 weeks | baseline to 12 weeks |
Countries
China
Outcome results
None listed