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NOT YET RECRUITING
NCT06910280
NA

Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer

Sponsor: Centre Hospitalier Universitaire de Besancon

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05

Completion Date

2026-11

Last Updated

2025-04-04

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

conservative surgery for breast cancer with local anesthesia

conservative surgery for breast cancer with local anesthesia

PROCEDURE

conservative surgery for breast cancer with general anesthesia

conservative surgery for breast cancer with general anesthesia

Locations (1)

CHU de Besancon

Besançon, Franche Comte, France