Surgery in Addition to the Medical Treatment of Lymphedema

NCT ID: NCT03776214

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Optimal Treatment of Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* no pitting edema
* good therapeutic compliance
* weight stability

Exclusion Criteria

\- under 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Department of Reconstructive surgery, UH Montpellier

UNKNOWN

Sponsor Role collaborator

Department of vascular medecine, UH Montpellier

UNKNOWN

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MESTRE GODIN Sandrine

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0133

Identifier Type: -

Identifier Source: org_study_id

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