Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

NCT ID: NCT02473744

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-27
• Study Completion Date: 2017-07-20

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.

Conditions

Edema

Keywords

lower limb edema; subcutaneous drainage; bioelectrical impedance; quality of life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

subcutaneous drainage

Intervention Type: OTHER

After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.

Interventions

subcutaneous drainage

After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand SARDIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

University hospital

Bordeaux, , France

University hospital

Limoges, , France

University hospital

Nantes, , France

Hospital

Périgueux, , France

Joseph Ducuing hospital

Toulouse, , France

University hospital

Toulouse, , France

Hospital

Valenciennes, , France

Countries

France

Other Identifiers

I14010 DSOPAL

Identifier Type: -

Identifier Source: org_study_id