Neoplasms

Skin and Connective Tissue Diseases

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20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction

It is an endoscopic approach for prophylactic mastectomy using an axillary single port

Prophylactic mastectomy with immediate breast reconstruction

Gauthier Rathat, MD

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy, using an axillary single port. Classic open surgery conversion rate, operative time, infectious rate, esthetical outcomes, and functional outcomes will be evaluated.

Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position.

Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis

Duration of the prophylactic mastectomy with immediate breast reconstruction

Number of participants with early postoperative infection two months after the prophylactic mastectomy

Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction

Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction

Number of patients with disunity of the scar after the prophylactic mastectomy

Number of patients with the prothesis exposed after the prophylactic mastectomy

Number of patients with seromas after the prophylactic mastectomy

Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)\> 45mmHg and refractory to ventilation ; second degree secondary burn

The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if \> 25%

The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.

The level of pain of the operated breasts will be self-assessed by the patient with EVA at 1, 3, 6, 12 months after the surgery. EVA is mesured between 0 and 10 (0: no pain ; 10: extremely intense pain)

The duration of hospitalization will be noted upon discharge from hospitalization

BREAST-Q© questionnaire Version 2.0 measure the quality of life and satisfaction among patients undergoing breast surgery. This questionnaire includes 6 modules: 1) Augmentation module, 2) Reduction/Mastectomy module, 3) Breast cancer: a) Mastectomy module, b) Reconstruction module, c) Breast reconstruction expectations module, d) Breast conserving therapy module.

The conceptual framework of the modules is comprised of following two overarching themes (or domains): 1) Health-related quality of life and 2) Patient satisfaction. 1) Under each of these domains, there are six subthemes; Quality of life: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with care.

Cf. https://qportfolio.org/wp-content/uploads/2020/BREAST-Q-USERS-GUIDE-V2.pdf for the response options.

the need to use one or more lipomodelages

Evaluation of the Constant score by a physiotherapist from the gynecology Department. The Constant score includes 5 items: Pain \[0;5\], Daily activity level \[0;10\], Level of work with the hand \[0;10\], Mobility \[0;40\] and Muscular force \[0;25\].

The Constant score is mesured between 0 and 100. The higher the score, the fewer problems there are for the patient, 100 is the ideal score.

Quality of life with an european quality of life scale (EQ-5D-3L). The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication	NCT03838549	Genetic Predisp... Breast Cancer	Prophylactic ma...	20 Years -	University Hospital, Montpellier
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication	NCT03838549	Genetic Predisp... Breast Cancer	Prophylactic ma...	20 Years -	University Hospital, Montpellier

Spots Global Cancer Trial Database for prophylactic surgical procedure