Lymphatic Venous Anastomosis for Secondary lymphedema.

Lymphatic Venous Anastomosis for Secondary lymphedema. - LVA for Lymphedema

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025137

Enrollment

120

Registered

2017-01-01

Start date

2017-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary lymphedema

Interventions

Lymphatic Venous Anastomosis Complex Decongestive Physiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Saitama kenjinkai Kawaguchi General Hospital Patients who received lymphatic surgery / reconstructive surgery 2) Patients diagnosed with secondary lower extremity lymphoedema by lymphoscintigraphy 3) Patients judged to have the ability to answer interrogation 4) Patients who obtained document consent by the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study. 5) In cases where the patient is a minor, 4) In addition to the patient caregiver sufficient understanding, document consent is obtained.

Exclusion criteria

Exclusion criteria: Exclusion criteria Patients who conflict with the following criteria shall not be included in this study. 1) Patients with postoperative observation period of less than 6 months 2) Patients with complication of edema due to heart failure / renal failure etc. 3) Cases judged inappropriate by test doctor

Design outcomes

Primary

Measure	Time frame
Evaluate with the change in the number of times of cellulitis. In the LVA group, the number of cellulitis times during 24 weeks before the start of intervention and 24 weeks after the start of the intervention is compared. In the CDP therapy group, we compare the number of times of cellulitis in 24 weeks before the allocation date and 24 weeks after the allocation date. Cellulitis is defined as having inflammatory findings such as redness and heat sensation on the affected limbs and having a fever of 38.5 degrees or more.	—

Measure

Time frame

Evaluate with the change in the number of times of cellulitis. In the LVA group, the number of cellulitis times during 24 weeks before the start of intervention and 24 weeks after the start of the intervention is compared. In the CDP therapy group, we compare the number of times of cellulitis in 24 weeks before the allocation date and 24 weeks after the allocation date. Cellulitis is defined as having inflammatory findings such as redness and heat sensation on the affected limbs and having a fever of 38.5 degrees or more.

—

Secondary

Measure	Time frame
1.Limb Circumference Measure with six tapes of 20 cm above the knee, 10 cm above the knee, knee joint, 10 cm below the knee, ankle joint and foot sole, and calculate the rate of change based on the following formula. Measurements are blinded by doing a nurse or a physical therapist who is not involved in surgery or research protocol creation. Change rate (%) = (Sum of surgical diameter after surgery - Sum of surrounding diameters before surgery) / Sum of peripheral diameter before surgery x 100 2.Pain and Discomfort Visual Analogue Scale (VAS) are used 3.Tissue Hardness Three kinds of urethane sponge with different hardness (Yawataneji K. K., Japan) are used, and the hardness of the skin and subcutaneous tissues of the affected limb is compared by palpation. Evaluate the distal inner and outer side of the lower leg, proximal inner and outer side of the lower thigh, inner side outer side of the thigh, inner side of the thigh and inner side and outer side of the thigh separately. Each sponge is numbered 2, 4, 6 according to the hardness, 2 points if it has the same hardness as 2, 1 point if it is softer than 2, 3 points if it is hardness between 2 and 4 Evaluate in seven stages of 1 to 7 and so on. This evaluation is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol. 4.QOL Using SF 36, we perform QOL evaluation before intervention and 6 months after intervention.	—

Measure

Time frame

1.Limb Circumference Measure with six tapes of 20 cm above the knee, 10 cm above the knee, knee joint, 10 cm below the knee, ankle joint and foot sole, and calculate the rate of change based on the following formula. Measurements are blinded by doing a nurse or a physical therapist who is not involved in surgery or research protocol creation. Change rate (%) = (Sum of surgical diameter after surgery - Sum of surrounding diameters before surgery) / Sum of peripheral diameter before surgery x 100 2.Pain and Discomfort Visual Analogue Scale (VAS) are used 3.Tissue Hardness Three kinds of urethane sponge with different hardness (Yawataneji K. K., Japan) are used, and the hardness of the skin and subcutaneous tissues of the affected limb is compared by palpation. Evaluate the distal inner and outer side of the lower leg, proximal inner and outer side of the lower thigh, inner side outer side of the thigh, inner side of the thigh and inner side and outer side of the thigh separately. Each sponge is numbered 2, 4, 6 according to the hardness, 2 points if it has the same hardness as 2, 1 point if it is softer than 2, 3 points if it is hardness between 2 and 4 Evaluate in seven stages of 1 to 7 and so on. This evaluation is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol. 4.QOL Using SF 36, we perform QOL evaluation before intervention and 6 months after intervention.

—

Countries

Japan

Contacts

Public ContactYoshinori Shimizu

Saiseikai Kawaguchi General Hospital Financial and legal department

zaimuhoumu@saiseikai.gr.jp048-253-1551

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026