Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

Edema Clinical Trial

— DSOPAL  

Official title:

Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02473744
• Other study ID #: I14010 DSOPAL
• Status: Terminated
• Phase: N/A
• First received: June 8, 2015
• Last updated: November 9, 2017
• Start date: July 27, 2015
• Est. completion date: July 20, 2017

Study information

• Verified date: November 2017
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema

Intervention

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

Locations

Country	Name	City	State
France	University hospital	Bordeaux
France	University hospital	Limoges
France	University hospital	Nantes
France	Hospital	Perigueux
France	Joseph Ducuing hospital	Toulouse
France	University hospital	Toulouse
France	Hospital	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Karnofsky's scale	Change in autonomy evaluated by Karnofsky's scale between Day 7 and Day 0	7 days
Secondary	Karnofsky's scale	Change in autonomy evaluated by Karnofsky's scale between Day 4 and Day 0	4 Days
Secondary	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	4 days and 7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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