Secondary lower extremity lymphedema Secondary lymphedema
Conditions
Interventions
As an adjunct therapy to lymphatic-venous anastomosis surgery, a pneumatic lymphatic drainage device is used for six months starting immediately after surgery.
Sponsors
Akita Shinsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 18 years or older at the time of informed consent 2) Patients with unilaterally diagnosed secondary lower limb lymphedema confirmed by scintigraphy, classified as clinical stage I or II 3) Patients scheduled for lymphatic-venous anastomosis surgery after initiating compression therapy preoperatively 4) Patients scheduled for surgery where safe wear of the PLD is possible starting on the day of surgery. 5) Patients who, after receiving sufficient explanation regarding participation in this trial, provided written informed consent of their own free will based on full understanding.
Exclusion criteria
Exclusion criteria: 1) Bilateral lymphedema 2) Patients simultaneously scheduled for bariatric surgery 3) Patients with concomitant venous disease Patients with concomitant venous disease 4) Patients with deep vein thrombosis, severe arterial disease, severe cardiac disease, inability to properly wear the sleeve, risk of fracture, severe skin disorders, severe sensory impairment in the lower limbs, acute abdominal disease, acute inflammatory disease of the lower limbs, pregnancy, or other conditions contraindicated for the study device 5) Patients for whom safe and continuous home use of PLD is anticipated to be difficult 6) Other patients deemed unsuitable for safe conduct of this trial by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of excess volume calculated based on circumference at 6 months post-surgery compared to pre-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy Endpoints 1. Improvement rate of excess volume over time at discharge, 1 month, 3 months, and 6 months 2. Improvement rate of bioimpedance at 6 months post-surgery 3. Improvement rate of bioimpedance over time at discharge, 1 month, 3 months, and 6 months 4. Patient-reported outcome score at 6 months post-surgery (using LYMQOL) 5. Incidence of cellulitis in the affected limb at 6 months post-surgery Safety Secondary Endpoints Presence of serious adverse events related to PLD use | — |
Contacts
Public ContactSHINSUKE AKITA
Chiba University Hospital
Outcome results
None listed