Lymphocele
Conditions
Keywords
mastectomy
Brief summary
Lymphocele secondary to a mastectomy whether or not associated with a lymph node procedure (sentinel lymph node or axillary dissection) is an almost systematic consequence observed in the postoperative situation in this type of surgery. This can be the source of pain, skin complications, and infection with a significant impact on the length of hospitalization for patients treated for breast cancer. There is no consensus regarding the management of lymphocele. The placement of a compression bandage after mastectomy and / or axillary dissection would allow a more efficient and rapid reduction of the lymphocele and a reduction in recurrences. This would make it possible to reduce the duration of the wearing of the drain, which determines the length of hospitalization and reduce the recurrence of lymphoceles, the punctures of which can be one of the risk factors for secondary lymphedema.
Interventions
DEVICEBandage
Bandage
DEVICENo bandage
No bandage
Sponsors
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old, * Undergoing mastectomy-type surgery with or without axillary dissection for breast cancer * Affiliated with a health insurance plan
Exclusion criteria
* Recurrence of breast cancer, * Mastectomy with RMI (immediate breast reconstruction) at the same time of operation * Anticoagulant treatment at curative dose * Arteritis obliterans of the upper limbs, * Other cancer during treatment, * Decompensated heart failure, * Acute infectious episode (cellulitis, erysipelas, lymphangitis) * Acute deep vein thrombosis upper limb ipsilateral to mastectomy, * Cutaneous atrophy of the upper limb, * Bullous dermatoses, * Hyperalgesia of the shoulder * Inability to submit to the constraints of the protocol, * Impossibility for the patient to achieve self-restraint at the thoracic level * Pregnancy, * Feeding with milk * BMI\> 35 * Adult protected by law (guardianship, curatorship and safeguard of justice). * Anyone who is not in a position to give their consent in writing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion in percentage of patients treated successfully | 6 months | Provide an estimate of the proportion of patients treated successfully (success rate defined by the absence of lymphocele on D4 post mastectomy) in two groups of patients (drain + compression bandage vs drain without compression bandage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocele volume in milliliter | 6 months | Lymphocele volume at day 4, day 8 and 6 months post mastectomy |
| Number of lymphocele punctures | 6 months | Number of lymphocele punctures possibly performed during the 6 months of follow-up |
| Clinical signs associated with lymphocele | 8 days | Clinical signs associated with lymphocele at day 4 and day 8 (redness, blister, local inflammation (erythema + redness + warmth), rash, pruritus, ecchymosis, wound, allergic reaction, presence of clinical lymphocele, pain in the limb ipsilateral on surgery, heaviness in the ipsilateral limb discomfort when using the ipsilateral limb, perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler, measurement of joint amplitudes (in centimeters). |
| Frequency of adverse events | 6 months | The frequency of adverse events during the 6-month follow-up |
| Changes in quality of life | 6 months | Changes in quality of life, with QLQ-C30 questionnaire, (specifically linked to breast cancer and overall quality of life) at day 8, day 21 and at 6 months post mastectomy, compared to an assessment before mastectomy |
Countries
France
Contacts
Primary ContactJulie MALLOIZEL DELAUNAY, MD
Backup ContactCharlotte VAYSSE
Outcome results
None listed