Oedematous Lower Limb Subcutaneous Drainage in Palliative Care (DSOPAL)
Primary Purpose
Edema
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
subcutaneous drainage
Sponsored by
About this trial
This is an interventional supportive care trial for Edema focused on measuring lower limb edema, subcutaneous drainage, bioelectrical impedance, quality of life
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.
Sites / Locations
- University hospital
- University hospital
- University hospital
- Hospital
- Joseph Ducuing hospital
- University hospital
- Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oedematous lower limb subcutaneous drainage
Arm Description
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.
Outcomes
Primary Outcome Measures
Karnofsky's scale
Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0
Secondary Outcome Measures
Karnofsky's scale
Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0
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),
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
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
Verbal numeric scale for pain
Changes in pain evaluated by the verbal numeric scale between Day 4/Day 7 and Day 0
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.
Segmental limb circumferences measurement
Variation of the physical measures in time. Changes in segmental limb circumferences between Day 4/Day 7 and Day 0
Abdominal perimeter measurement
Variation of the physical measures in time. Changes in abdominal perimeter between Day 4/Day 7 and Day 0
Weight measurement
Variation of the physical measures in time. Changes in weight between Day 4/Day 7 and Day 0
Full Information
NCT ID
NCT02473744
First Posted
June 8, 2015
Last Updated
November 9, 2017
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02473744
Brief Title
Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
Acronym
DSOPAL
Official Title
Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Not enough patients
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema
Keywords
lower limb edema, subcutaneous drainage, bioelectrical impedance, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oedematous lower limb subcutaneous drainage
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
subcutaneous drainage
Intervention Description
After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.
Primary Outcome Measure Information:
Title
Karnofsky's scale
Description
Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Karnofsky's scale
Description
Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0
Time Frame
4 Days
Title
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),
Description
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
Time Frame
4 days and 7 days
Title
Modify Dermatology Life Quality Index (MDLQI)
Description
Changes in quality of life related to lymphedema evaluated by the MDLQI between Day 4/Day 7 and Day 0
Time Frame
4 days and 7 days
Title
Verbal numeric scale for pain
Description
Changes in pain evaluated by the verbal numeric scale between Day 4/Day 7 and Day 0
Time Frame
4 days and 7 days
Title
Bioelectrical impedance analysis of lower limbs, calves and thighs
Description
Changes in bioelectrical impedance of lower limbs, calves and thighs between Day 4/Day 7 and Day 0.
Time Frame
4 days and 7 days
Title
Segmental limb circumferences measurement
Description
Variation of the physical measures in time. Changes in segmental limb circumferences between Day 4/Day 7 and Day 0
Time Frame
4 days and 7 days
Title
Abdominal perimeter measurement
Description
Variation of the physical measures in time. Changes in abdominal perimeter between Day 4/Day 7 and Day 0
Time Frame
4 days and 7 days
Title
Weight measurement
Description
Variation of the physical measures in time. Changes in weight between Day 4/Day 7 and Day 0
Time Frame
4 days and 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand SARDIN, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
University hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
University hospital
City
Nantes
ZIP/Postal Code
40031
Country
France
Facility Name
Hospital
City
Perigueux
ZIP/Postal Code
24019
Country
France
Facility Name
Joseph Ducuing hospital
City
Toulouse
ZIP/Postal Code
31027
Country
France
Facility Name
University hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hospital
City
Valenciennes
ZIP/Postal Code
59300
Country
France
12. IPD Sharing Statement
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Oedematous Lower Limb Subcutaneous Drainage in Palliative Care
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