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Oedematous Lower Limb Subcutaneous Drainage in Palliative Care (DSOPAL)

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ClinicalTrials.gov Identifier: NCT02473744
Recruitment Status : Terminated (Not enough patients)
First Posted : June 17, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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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.

Condition or disease Intervention/treatment Phase
Edema Other: subcutaneous drainage Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
Actual Study Start Date : July 27, 2015
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oedematous lower limb subcutaneous drainage
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.
 Other: subcutaneous drainage
After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.


Outcome Measures
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Primary Outcome Measures :
  1. Karnofsky's scale [ Time Frame: 7 days ]
    Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0


Secondary Outcome Measures :
  1. Karnofsky's scale [ Time Frame: 4 Days ]
    Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0

  2. 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), [ Time Frame: 4 days and 7 days ]
    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

  3. Modify Dermatology Life Quality Index (MDLQI) [ Time Frame: 4 days and 7 days ]
    Changes in quality of life related to lymphedema evaluated by the MDLQI between Day 4/Day 7 and Day 0

  4. Verbal numeric scale for pain [ Time Frame: 4 days and 7 days ]
    Changes in pain evaluated by the verbal numeric scale between Day 4/Day 7 and Day 0

  5. Bioelectrical impedance analysis of lower limbs, calves and thighs [ Time Frame: 4 days and 7 days ]
    Changes in bioelectrical impedance of lower limbs, calves and thighs between Day 4/Day 7 and Day 0.

  6. Segmental limb circumferences measurement [ Time Frame: 4 days and 7 days ]
    Variation of the physical measures in time. Changes in segmental limb circumferences between Day 4/Day 7 and Day 0

  7. Abdominal perimeter measurement [ Time Frame: 4 days and 7 days ]
    Variation of the physical measures in time. Changes in abdominal perimeter between Day 4/Day 7 and Day 0

  8. Weight measurement [ Time Frame: 4 days and 7 days ]
    Variation of the physical measures in time. Changes in weight between Day 4/Day 7 and Day 0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473744


Locations
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France
University hospital
Bordeaux, France, 33000
University hospital
Limoges, France, 87042
University hospital
Nantes, France, 40031
Hospital
Perigueux, France, 24019
Joseph Ducuing hospital
Toulouse, France, 31027
University hospital
Toulouse, France, 31059
Hospital
Valenciennes, France, 59300
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Bertrand SARDIN, MD University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02473744    
Other Study ID Numbers: I14010 DSOPAL
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by University Hospital, Limoges:
lower limb edema
subcutaneous drainage
bioelectrical impedance
quality of life
Additional relevant MeSH terms:
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Edema