PREvention of Post-mastectomy LYMphoceles by PAdding (PRELYMCA)
PREvention of Post-mastectomy LYMphoceles by PAdding. A Randomized Prospective Multicenter Study
Lymphoceles, or seromas, are the most frequent complication following mastectomy and are associated or not with axillary dissection occurring in 10 to 90% of cases. It is defined as the presence of a palpable post operative serous accumulation that is bothersome for the patient and requires a puncture and drainage or even several repeated punctures. The presence of seromas is therefore associated with discomfort and pain. Seromas could also be responsible for increased morbidity due to complications such as infection, suture separating, lymphedema, prolonged of hospital stay, or a delay in initiation of adjunct treatment (e.g. chemotherapy, radiotherapy). Some risk factors have been identified, such as obesity, increased post operative drainage of J1 to J3, and arterial hypertension.
Different measures have demonstrated the benefits of limiting axillary lymphoceles after dissection : placement of a drain, padding and delay in shoulder mobility.
Studies have shown that axillary padding decreases lymphocele development and shortens the length of hospital stay. Some studies based on padding of the mastectomy site also have shown a decrease in post operative seromas; however no study has been done on the usefulness of padding in the mastectomy site alone because they include both padding and a drain or padding of the axillary area.
The padding technique the investigators employ is performed at the donor site in breast reconstruction by latissimus dorsi muscle flap, demonstrating a reduction in the rate of seromas.
In this study, the classic technique will be compared to padding in the mastectomy site with short drainage (48h).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
Compiègne, France, 60321
- CH Compiègne
-
Soissons, France, 02209
- CH Soissons
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Female gender
- Patients with infiltrating or in situ breast cancer
- Indication of surgical treatment by mastectomy
- Patient providing written informed consent
- Patient with health insurance coverage
- Ability to provide voluntary written informed consent
Exclusion Criteria:
- Informed consent cannot be obtain
- Pregnant or lactating women
- Patients undergoing immediate breast reconstruction
- Patients with cancer untreatable by mastectomy, non curative mastectomy: partial mastectomies, preventive mastectomies (BRCA genetic mutations)
- Patients under legal protection or unable to come to a center
- Patients unable to express voluntary consent
- Patients receiving post operative anticoagulants or platelet antiaggregants
- Patients requiring postoperative anticoagulants
- Bilateral mastectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: classic closure
mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration
|
mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration
|
|
Experimental: padding
areas of padding and stiching between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h.
|
areas of padding and running sutures between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative lymphoceles
Time Frame: Day 15
|
presence or absence of postoperative lymphoceles
|
Day 15
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2013_843_0001
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