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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
It is an endoscopic approach for prophylactic mastectomy using an axillary single port
Montpellier University Hospital
Montpellier, Hérault, France
success rate of total mastectomy
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
Time frame: one day
Operative time
Duration of the prophylactic mastectomy with immediate breast reconstruction
Time frame: one day
Open surgery conversion rate
Open surgery conversion rate
Time frame: one day
Number of participants with an infection
Number of participants with early postoperative infection two months after the prophylactic mastectomy
Time frame: 1 and 3 months after the prophylactic mastectomy
Blood loss
Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
Time frame: one day
Number of participants with a local haematoma
Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction
Time frame: Between the day of the prophylactic mastectomy and a month later
Disunity of the scar
Number of patients with disunity of the scar after the prophylactic mastectomy
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Exposure of the prosthesis
Number of patients with the prothesis exposed after the prophylactic mastectomy
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Post-operative seromas after the prophylactic mastectomy
Number of patients with seromas after the prophylactic mastectomy
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Complication rate of subcutaneous insufflation
Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)\> 45mmHg and refractory to ventilation ; second degree secondary burn
Time frame: 3 and 12 months after the prophylactic mastectomy
Skin case necrosis
The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if \> 25%
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Necrosis of areolo-nipple plaque
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Analogue visual scale (EVA)
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)
Time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
Hospital stay
The duration of hospitalization will be noted upon discharge from hospitalization
Time frame: Through discharge from hospitalization, an average of 7 days
Aesthetic result
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.
Time frame: 3 and 12 months after the prophylactic mastectomy
Need for cosmetic reoperation
the need to use one or more lipomodelages
Time frame: 3 and 12 months after the prophylactic mastectomy
Shoulder function
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.
Time frame: 3 months after the prophylactic mastectomy
Life quality
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).
Time frame: 3 and 12 months after the prophylactic mastectomy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.