NIPH Clinical Trials Search

A Study on the Efficacy of Air-Pressure Pump-Assisted Lymphatic Drainage Following Lymphatic-Venous Anastomosis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Secondary lower extremity lymphedema
Date of first enrollment	24/12/2025
Target sample size	64
Countries of recruitment
Study type	Interventional
Intervention(s)	As an adjunct therapy to lymphatic-venous anastomosis surgery, a pneumatic lymphatic drainage device is used for six months starting immediately after surgery.

Outcome(s)

Primary Outcome

Improvement rate of excess volume calculated based on circumference at 6 months post-surgery compared to pre-surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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