Secondary lymphedema
Conditions
Interventions
As a surgical treatment, removal of subcutaneous tissues in which elephant-like degenerated skin and fibrosis have progressed, liposuction and the like have been carried out, but JR Tokyo General Hosp
Sponsors
JR tokyo general Hospital BETHEL MINAMI-Shinjuku clinic Mihara Interanal medicine clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who received JR Tokyo General Hospital lymphatic surgery / reconstructive surgery 2) Patients diagnosed with secondary lower extremity lymphedema by lymphoscintigraphy 3) Patients who have conservative therapy for more than 3 months already 4) Patients judged to have the ability to answer inquiries 5) Patients who obtained written consent from the patients themselves freely with sufficient understanding after receiving sufficient explanation for participation in this study. 6) In the case that the patient is a minor, 5) In addition to the case that the patient guardian fully understands and obtains written consent.
Exclusion criteria
Exclusion criteria: Patients who conflict with the following criteria shall not be included in this study. 1) Patients who can be expected to have a postoperative follow-up period of less than 6 months at JR Tokyo General Hospital, Bethel Minami Shinjuku Clinic, Medical Corporation Mihara Internal Medicine 2) Patients with complication of edema due to heart failure, renal failure, etc. 3) Cases judged inappropriate by the doctor sharing test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate based on the change in the number of times of cellulitis. In the LVA group, the number of times of cellulitis inflammation during 24 weeks before the start of the intervention and 24 weeks after the start of the intervention is compared. In the conservative therapy group, we compare the number of times of cellulitis in 24 weeks before the allocation date and 24 weeks after the allocation date. Huigong weeping inflammation is defined as having inflammatory findings such as redness and heat sensation on the affected limb and having a fever of 38.5 degrees or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.circumference of affected limb 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. Measurement is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol creation. Change rate (%) = (Sum of surrounding diameters after operation - Sum of surrounding diameters before surgery) / Sum of peripheral diameter before surgery x 100 2.Pain, discomfort (subjective symptoms) Record using visual analogue scale (VAS). 3.Subcutaneous tissue hardness Three types of urethane sponge with different hardness (Yawata Tayzen Co., Ltd.) are used to compare this with the firmness of the skin and subcutaneous tissue of the affected limb by palpation. Evaluate the distal inner and outer side of the lower leg, proximal inner and outer sides of the lower limb, distal inner and outer sides of the thigh, inner side of the thigh and inner side and outer side of the thigh. Each sponge is numbered 2, 4, 6 according to the hardness, 2 points if it is 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 points. This evaluation is blinded by doing a nurse or a physical therapist who is not involved in surgery and research protocol creation. | — |
Countries
Japan
Contacts
Public ContactHisako Hara
JR Tokyo General Hospital Lymphatic and Reconstructive Surgery
Outcome results
None listed