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• Abstract : In palliative care, lymphedema results from various associations of cancer, hypoalbuminemia, electrolytic disturbances or organ failure. The lymphatic circulation cannot be summarized by the Starling's equation and obstruction cannot explain everything. An interstitial hypothesis underlines the role of the lymphatic pump and edema volume can be a crucial point. The SDO, via the direct liquid removal, can restore the lymphatic pump function. This volumetric effect can explain the long time effect of the SDO and the large range of liquid amount reported in effective SDO. The superficial lymphatic system, in the superficial layer of derma, drains 80 % of lymph flow. In edema, the increased volume leads to the creation of subcutaneous interconnected lacunas. The subcutaneous site for drainage is justified.
After topic anesthesia, three subcutaneous channels are created on the ankle's medial face of the edematous limbs and liquids are absorbed by pads. An additional drainage can be done on the external face of the thigh with liquid collecting bags in bedridden patients.
The study includes clinical examination, total and segmental bioelectrical impedance measured at J0, J4 and on exit or at J7 at the latest and daily weight, umbilic abdominal perimeters and segmental circumferences and QOL evaluation before and after SDO. Bioelectrical impedance is collected from hand-foot, thigh root-foot and under patella calf - foot electrodes. Segmental circumferences are collected at thigh, calf and ankle points identified from bone relief distance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oedematous lower limb subcutaneous drainage | Experimental | In case of lymphoedema in palliative situation, a subcutaneous drainage can be performed. It is a simple method, easy to use. After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous drainage | Other | After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Karnofsky's scale | Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Karnofsky's scale | Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0 | 4 Days |
| The 15th item of the European Organisation for Research and Treatment of Cancer quality of life questionnaires of palliative cancer care patients (EORTC QLQ C15 PAL), |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertrand SARDIN, MD | University Hospital, Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Bordeaux | 33000 | France | |||
| University hospital |
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| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Changes in quality of life evaluated by the 15th item of the EORTC QLQ C15 PAL scale between between Day 4/Day 7 and Day 0 |
| 4 days and 7 days |
| Modify Dermatology Life Quality Index (MDLQI) | Changes in quality of life related to lymphedema evaluated by the MDLQI between Day 4/Day 7 and Day 0 | 4 days and 7 days |
| Verbal numeric scale for pain | Changes in pain evaluated by the verbal numeric scale between Day 4/Day 7 and Day 0 | 4 days and 7 days |
| Bioelectrical impedance analysis of lower limbs, calves and thighs | Changes in bioelectrical impedance of lower limbs, calves and thighs between Day 4/Day 7 and Day 0. | 4 days and 7 days |
| Segmental limb circumferences measurement | Variation of the physical measures in time. Changes in segmental limb circumferences between Day 4/Day 7 and Day 0 | 4 days and 7 days |
| Abdominal perimeter measurement | Variation of the physical measures in time. Changes in abdominal perimeter between Day 4/Day 7 and Day 0 | 4 days and 7 days |
| Weight measurement | Variation of the physical measures in time. Changes in weight between Day 4/Day 7 and Day 0 | 4 days and 7 days |
| Limoges |
| 87042 |
| France |
| University hospital | Nantes | 40031 | France |
| Hospital | Périgueux | 24019 | France |
| Joseph Ducuing hospital | Toulouse | 31027 | France |
| University hospital | Toulouse | 31059 | France |
| Hospital | Valenciennes | 59300 | France |