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Surgery in Addition to the Medical Treatment of Lymphedema

LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03776214
Acronym
LYMPHOSPIR
Enrollment
1000
Registered
2018-12-14
Start date
2018-04-01
Completion date
2019-12-31
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimal Treatment of Lymphedema

Keywords

No pitting edema, After medical and surgical evaluation, Microlipoaspiration, surgery, lymphedema

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.

Interventions

None listed

Sponsors

Department of Reconstructive surgery, UH Montpellier
CollaboratorUNKNOWN
Department of vascular medecine, UH Montpellier
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* no pitting edema * good therapeutic compliance * weight stability

Exclusion criteria

\- under 18 years old

Design outcomes

Primary

MeasureTime frameDescription
quality of life (self questionnaire LYMQOL)1 dayTo evaluate the impact of surgery in addition to the medical management of lymphedema on the quality of life of operated patients between preoperative and postoperative

Secondary

MeasureTime frameDescription
volume of operated limb1 dayEvaluate the effectiveness of surgery in addition to medical management in terms of volume reduction of the operated limb between preoperative and postoperative.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026