Unique ID issued by UMIN | UMIN000004036 |
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Receipt number | R000004857 |
Scientific Title | Rehabilitation for secondary lymphedema of lower limbs Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation |
Date of disclosure of the study information | 2010/09/01 |
Last modified on | 2014/08/13 13:29:47 |
Rehabilitation for secondary lymphedema of lower limbs
Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation
Rehabilitation and ICG lymphography for secondary lymphedema of lower limbs
Rehabilitation for secondary lymphedema of lower limbs
Lymphatic transportation measurement with ICG lymphography and the effect of rehabilitation
Rehabilitation and ICG lymphography for secondary lymphedema of lower limbs
Japan |
Secondary lymphedema
Vascular surgery | Plastic surgery | Rehabilitation medicine |
Others
NO
To verify the ability of lymphatic transportation and the effect of rehabilitation using ICG lymphography for secondary lymphedema
Efficacy
Exploratory
Pragmatic
Phase I
1.function of lymphatic transportation
2. image of ICG lymphography
1.diameter of lower limb
2.thickness of skin tissue
3.sepecific symptoms related to lymphedema
Interventional
Parallel
Non-randomized
Open -no one is blinded
Uncontrolled
4
Treatment
Maneuver |
Method of ICG lymphography
1) supine position at rest(10 minutes).
2) Subcutaneous infusion of the dorsum of foot with 0.5ml of 1% Xylocain with a 29-gauge needle.
3) Bandage-like compression of a lower leg (Manchette compression is applied at 70 mmHg with a sphygmomanometer).
4) Subcutaneous infusion of the dorsum of foot with 0.3ml. of 5% ICG (indocyanine green) solution with a 29-gauge needle.
5) Imaging of lymphatic vessel using an infrared camera system (PDE, Hamamatsu Photonics).
6) Rubbing an injection part lightly and guide ICG in lymphatic vessel.
7) Measurement of the minimal pressure which inhibit to start flowing ICG (Manchette compression is reduced by 10mmHg every 3 minutes (minimal inhibition pressure).
8) Measurement of the time to transport ICG from injected site to knee or inguinal area (transit time).
9) Scoring of the specific image of ICG lymphography (dermal back flow, local dilatation, stoppage and expansion meandering, diffuse and scattering signal).
Evaluation of reliability
Confirming the reproducibility of the ICG lymphography using Intraclass Correlation (ICC) between two measurements at an interval of two weeks or more.
Evaluation of change over time
If necessary, the ICG lymphography is performed before and 1, 2, 3 and 6 months after pelvic lynphadenectomy.
Evaluation of validity
1) Measurement of the leg lap diameter (above knee 20cm and 10cm, below knee 10cm and 20cm, ankle, dorsum of foot).
2) Measurement of the subcutaneous tissue thickness using the ultrasonic echo.
3) Collecting demographic data, physical examination (height, weight, Body mass index, age, sex, history of operation, treatment career of the past, current treatment contents, a period to the lymphoedema onset, the degree of the pressure trace, degree of the skin hardening, Clinical stage scale for classification of a lymphedematous limb)
4) Statistical analysis of the correlation between clinical data and transit time, minimal inhibition pressure, and specific image of ICG lymphography.
Exercise load
We measure the transit time between baseline and after 5 min knee flexion-extension exercise.
Rehabilitation (Lymph drainage)
We measure the transit time between baseline and after 20 min rehabilitation(manual lymph drainage by physical therapist).
20 | years-old | <= |
80 | years-old | >= |
Female
1. secondary lymphedema
2. lymphedema of lower limb
3. caused by uterus cancer, ovarian cancer and their therapies
1.phlegmonitis
2.leakage of lymphatic fluid
3.deep venous thrombosis and sever aneurysm
4.poor general status(Performance Status 3 or more)
5.acute generalized inflammation and fever(38.0 centidegree or more)
6.severe heart failure
7.pulmonary embolism, acute respiratory failure, severe pulmonary hypertension
8.severe hepatic and renal failure
9.severe mental disorder, sever psychological diseases
10.other metabolic disorders (acute thyroiditis etc.)
140
1st name | |
Middle name | |
Last name | Tetsuya Tsuji |
Keio University, School of Medicine
Department of Rehabilitation Medicine
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
03-5363-3833
cxa01423@nifty.com
1st name | |
Middle name | |
Last name | Taro Okitsu |
Keio University, School of Medicine
Department of Rehabilitation Medicine
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
03-5363-3833
PXW13537@nifty.com
Keio University, School of Medicine
Ministry of Education, Culture, Sports, Science and Technology Training for Oncology Professionals in 9 universities
(in 2010)
Japan
NO
慶應義塾大学病院(東京都)
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 21 | Day |
2010 | Year | 09 | Month | 01 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2014 | Year | 07 | Month | 31 | Day |
2010 | Year | 08 | Month | 12 | Day |
2014 | Year | 08 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004857
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