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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Bandage
No bandage
University Hospital
Toulouse, France
RECRUITINGProportion in percentage of patients treated successfully
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).
Time frame: 6 months
Lymphocele volume in milliliter
Lymphocele volume at day 4, day 8 and 6 months post mastectomy
Time frame: 6 months
Number of lymphocele punctures
Number of lymphocele punctures possibly performed during the 6 months of follow-up
Time frame: 6 months
Clinical signs associated with lymphocele
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).
Time frame: 8 days
Frequency of adverse events
The frequency of adverse events during the 6-month follow-up
Time frame: 6 months
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 : perimeter measurements (in centimeters) at the level of both upper limbs using a standard seamstress ruler
Time frame: 8 days
Clinical signs associated with lymphocele
Clinical signs associated with lymphocele at day 4 and day 8 : measurement of joint amplitudes (in centimeters).
Time frame: 8 days
Changes in quality of life
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
Time frame: 6 months
Changes in quality of life
Changes in quality of life, with 5Q-5D-5L 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
Time frame: 6 months
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