Surgery in Addition to the Medical Treatment of Lymphedema (LYMPHOSPIR)

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

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.

Study Overview

• Status: Completed
• Conditions: Optimal Treatment of Lymphedema

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• no pitting edema
• good therapeutic compliance
• weight stability

Exclusion Criteria:

- under 18 years old

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life (self questionnaire LYMQOL)	To 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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume of operated limb	Evaluate the effectiveness of surgery in addition to medical management in terms of volume reduction of the operated limb between preoperative and postoperative.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Department of Reconstructive surgery, UH Montpellier; Department of vascular medecine, UH Montpellier
• Investigators: Principal Investigator: MESTRE GODIN Sandrine, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: surgery; lymphedema; No pitting edema; After medical and surgical evaluation; Microlipoaspiration
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: RECHMPL18_0133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No