Clinical trial NCT03776214: Surgery in Addition to the Medical Treatment of Lymphedema
Official title: LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optimal Treatment of Lymphedema
Keywords: No pitting edema
After medical and surgical evaluation
Microlipoaspiration
surgery
lymphedema
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Department of Reconstructive surgery, UH Montpellier
name: Department of vascular medecine, UH Montpellier
First posted: 2018-12-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with lymphedema (primary or secondary) of arm or limb selected by the medical and chirurgical staff (no pitting edema, optimal medical treatment, good therapeutic compliance) for an liposuccion or dermolipectomia.

Brief summary: Lymphedema is a chronic pathology with a real impact on the quality of life of patients. Despite optimal medical management of patients, some patients still have no pitting edema on which the medical treatment has no effect.

It is adipose tissue secondary to the evolution of lymphedema. It is often painful and important in terms of volume with the resulting functional consequences. The investigators propose to these patients a surgical management complementary to the optimal medical treatment by microlipoaspiration associated or not with a dermolipectomy. This surgical management began in 2014 in our service. The investigators want to evaluate the impact on quality of life of patients in this surgical management in addition to medical care.

Detailed description: Detailed Description:

This is a monocentric, observational cohort study.

Main judgment criteria:

Evolution of the quality of life score of the LYMQOL self-questionnaire between preoperative and postoperative (at 3.6 and 12 months) The investigators used a French translation of Keeley's LYMQOL (Quality Of Life Measure for Limb Lymphoedema) self-administered questionnaire in 2010 (2) to assess the quality of life of patients. This is a lymphedema specific questionnaire for which there is one version for the upper limb and one for the lower limb. Limb function, lymphedema symptoms, body image and mood are assessed independently. It allows to obtain a score between 1 and 4 which corresponds to the discomfort felt. The higher the score, the better the quality of life. It also includes, in the last question, a numerical scale allowing the patient to note her quality of life between 0 and 10.

Since 2016, patients have systematically completed quality of life questionnaires. Perimeter measurements are also done systematically at each visit, these data are available in the patient's computerized medical records (Dx Care).

Secondary judgment criterion:

Difference in the volume of the limb operated between preoperative and postoperative (3, 6 and 12 months)

The volume is calculated on the basis of stepped circumferential measurements (every 10 cm starting from the patella for the lower limb and every 5 cm starting from the bend of the elbow for the upper limb). These measures are taken at each consultation by our physiotherapists, specialized nurses or vascular doctors.

It is therefore a question of retrospectively analyzing the data collected.

The data will then be anonymised by a two-letter code and a number and will be entered on a Excel file available on a secure directory of the CHU for analysis.

A dedicated support protocol is already implemented in the Cf Appendix service. There are no special modalities for patients not included in the study.

Eligibility criteria: Inclusion Criteria:

* no pitting edema
* good therapeutic compliance
* weight stability

Exclusion Criteria:

- under 18 years old

Primary outcomes:
measure: quality of life (self questionnaire LYMQOL)
timeFrame: 1 day
Secondary outcomes:
measure: volume of operated limb
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: MESTRE GODIN Sandrine
role: PRINCIPAL_INVESTIGATOR
References: