The conservative surgery for breast cancer is the first treatment for cancer and includes : * A partial mastectomy (removal of part of the breast) * A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast). This is a common procedure in the gynecology operating room, usually performed under general anesthesia. However, with surgical advancements and less invasive procedures, it has become possible and common for patients to undergo surgery in our department under local anesthesia. No data in the medical literature has yet evaluated this new anesthetic approach. Through this study, we aim to assess the feasibility and acceptability of partial mastectomy surgery with sentinel lymph node removal under either local anesthesia or general anesthesia. The ultimate goal of this study is to allow future patients to benefit from faster outpatient surgery, requiring less hospital stay, and to continue the progress of minimizing surgical interventions that has already been successfully undertaken in breast cancer treatment. This is an interventional study because it involves randomization, which determines for each enrolled patient whether they will receive general anesthesia or local anesthesia. It is a feasibility and acceptability study It is important to note that the surgery itself will not differ between the two groups: only the method of anesthesia will change. This research is being conducted at the University Hospital of Besançon and only at this center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
60
conservative surgery for breast cancer with local anesthesia
conservative surgery for breast cancer with general anesthesia
CHU de Besancon
Besançon, Franche Comte, France
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Recruitment capacity : number of women per month meeting the inclusion criteria
Time frame: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Acceptability : proportion of patients who accepted inclusion in the study among those to whom it was proposed
Time frame: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Adherence : proportion of women included in the study who do not withdraw their consent before the start of surgery
Time frame: 2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Completeness : proportion of questionnaires completed at each time point of the study
Time frame: 3 months
Describe the effectiveness and success of conservative surgery, including partial mastectomy combined with sentinel lymph node biopsy under non-tumescent local anesthesia without sedation in breast cancer
Proportion of surgical procedures in which the entire operative procedure could be performed under local anesthesia without the need for general anesthesia.
Time frame: 3 months
Quantify postoperative pain in both arms of the study
Numerical rating scale for pain assessment 2 hours after leaving the operating room, 24 hours after discharge from the hospital, and 15 days after the procedure. Numerical rating scale for pain assessment and DN2 score at 3 months post-procedure.
Time frame: 15 days
Quantify postoperative satisfaction and well-being in both arms of the study.
BREAST-Q - Breast Conserving Therapy Module Subscales of the BREAST-Q: Scale 6: Physical well-being: breast (preoperative) Scale 7: Physical well-being: breast (postoperative)
Time frame: 3 months
Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.
Need for reoperation of the breast (margins considered positive in case of 'at ink' involvement \[tumor in contact with the ink\] for the infiltrative component and possibly associated in situ component) Need for reoperation of the axillary region Allergic reactions Other side effects related to general or local anesthesia Postoperative surgical complications (hematoma, abscess, wound dehiscence) Length of hospital stay Death
Time frame: 3 months
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