An interventional study of conservative surgery for breast cancer with local anesthesia and conservative surgery for breast cancer with general anesthesia in Breast Cancer, sponsored by Centre Hospitalier Universitaire de Besancon. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Screening
The conservative surgery for breast cancer is the first treatment for cancer and includes :
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 449 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
local anesthesia
Procedure: conservative surgery for breast cancer with local anesthesia
general anesthesia
Procedure: conservative surgery for breast cancer with general anesthesia
conservative surgery for breast cancer with local anesthesia
conservative surgery for breast cancer with general anesthesia
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
Start is estimated for May 2025; primary completion for Aug 2026, 15 months later.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 15 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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