Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female over 18 years of age
- •Diagnosis of invasive breast cancer (histological proof via breast biopsy)
- •Tumor size less than or equal to clinical T2 according to the current cTNM classification for breast cancer"
- •No clinical and/or radiological evidence of lymph node involvement
- •Affiliation to a French social security scheme or beneficiary of such a scheme
- •Approval in the multidisciplinary tumor board meeting for conservative treatment with partial mastectomy combined with sentinel lymph node biopsy
- •Signed informed consent indicating that the patient understands the purpose and procedures required by the study and agrees to participate in the study and comply with its requirements and restrictions
排除标准
- •Severe and morbid obesity (BMI strictly greater than 35)
- •Emaciation (BMI strictly less than 18.5)
- •Contraindication to the medications used in the protocol
- •Contraindication to general anesthesia
- •Contraindication to the local anesthesia protocol
- •Tumor considered non-resectable under local anesthesia according to the surgeon's assessment
- •Bifocal tumor
- •Associated oncoplastic procedure
- •Contralateral surgical procedure (implantable port placement, mastopexy, partial or total mastectomy)
- •Withdrawal of consent prior to surgery
- •Legal incapacity or limited legal capacity
- •Non-fluency in the French language or poor understanding as anticipated by the investigator
- •Subject without health insurance
- •Pregnant woman
- •Subject currently in the exclusion period of another study or listed in the national volunteer registry
研究组 & 干预措施
With local anesthesia
local anesthesia
干预措施: conservative surgery for breast cancer with local anesthesia (Procedure)
With general anesthesia
general anesthesia
干预措施: conservative surgery for breast cancer with general anesthesia (Procedure)
结局指标
主要结局
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.
时间窗: 3 months
Completeness : proportion of questionnaires completed at each time point of the study
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.
时间窗: 2 years
Recruitment capacity : number of women per month meeting the inclusion criteria
次要结局
- 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(3 months)
- Quantify postoperative pain in both arms of the study(15 days)
- Quantify postoperative satisfaction and well-being in both arms of the study.(3 months)
- Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.(3 months)