Clinical trial NCT02473744: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
Official title: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Edema
Keywords: lower limb edema
subcutaneous drainage
bioelectrical impedance
quality of life
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: * Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria.
* Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

Detailed description: • 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* palliative care patients
* Karnofsky Scale \< 50%
* Uni or bilateral lower limb oedema even if associated with lumbar or pelvi-scrotal oedema or ascitis whatever etiology involved (cancer, organ failure, hypoalbuminemia...)
* Effective Social security regimen affiliation
* Signed informed consent

Exclusion Criteria:

* Refusal to take part in the study
* Local anesthesic contraindication
* Infected skin lesions.

Primary outcomes:
measure: Karnofsky's scale
timeFrame: 7 days
Secondary outcomes:
measure: Karnofsky's scale
timeFrame: 4 Days
measure: 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),
timeFrame: 4 days and 7 days
measure: Modify Dermatology Life Quality Index (MDLQI)
timeFrame: 4 days and 7 days
measure: Verbal numeric scale for pain
timeFrame: 4 days and 7 days
measure: Bioelectrical impedance analysis of lower limbs, calves and thighs
timeFrame: 4 days and 7 days
measure: Segmental limb circumferences measurement
timeFrame: 4 days and 7 days
measure: Abdominal perimeter measurement
timeFrame: 4 days and 7 days
measure: Weight measurement
timeFrame: 4 days and 7 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University hospital
city: Limoges
country: France
facility: University hospital
city: Nantes
country: France
facility: University hospital
city: Perigueux
country: France
facility: Hospital
city: Toulouse
country: France
facility: Joseph Ducuing hospital
city: Toulouse
country: France
facility: University hospital
city: Valenciennes
country: France
facility: Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Bertrand SARDIN, MD
role: PRINCIPAL_INVESTIGATOR
References: