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

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ClinicalTrials.gov Identifier: NCT03776214
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
Department of Reconstructive surgery, UH Montpellier
Department of vascular medecine, UH Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

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.


Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: LYMPHOSPIR : Impact of Surgery in Addition to Optimal Management of Lymphedema.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema




Primary Outcome Measures :
  1. quality of life (self questionnaire LYMQOL) [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. volume of operated limb [ Time Frame: 1 day ]
    Evaluate the effectiveness of surgery in addition to medical management in terms of volume reduction of the operated limb between preoperative and postoperative.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • no pitting edema
  • good therapeutic compliance
  • weight stability

Exclusion Criteria:

- under 18 years old


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03776214


Contacts
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Contact: MESTRE GODIN Sandrine, MD, PhD 467337028 ext 33 s-mestre@chu-montpellier.fr
Contact: VALDELIEVRE Emilie, MD 467337028 ext 33 e-valdelievre@chu-montpellier.fr

Locations
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France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: MESTRE GODIN Sandrine    467337028 ext 33    s-mestre@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Department of Reconstructive surgery, UH Montpellier
Department of vascular medecine, UH Montpellier
Investigators
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Principal Investigator: MESTRE GODIN Sandrine University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03776214     History of Changes
Other Study ID Numbers: RECHMPL18_0133
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
No pitting edema
After medical and surgical evaluation
Microlipoaspiration
surgery
lymphedema

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases