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

University Hospital Center (CHU)

Status: Completed

Conditions: Breast Cancer; Genetic Predisposition

Treatments: Procedure: Prophylactic mastectomy with immediate breast reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT03838549

RECHMPL18_0244

UF 7672 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
• Ask an immediate breast reconstruction during the surgery
• World Heath Organization score <3
• Glandular volume : french bra cup size A, B ou C
• Glandular ptosis <=2 (Classification and Algorithm for Treatment of Breast Ptosis)
• Contraception for woman of childbearing age and no pregnancy
• Valid Social Security
• Wrote consent

Exclusion criteria

• History of breast cancer surgery
• Breast cancer not operated on the side concerned by the prophylactic mastectomy
• Patient having had irradiant treatment
• Breast hypertrophy
• Smoking > 10 cigarette/day
• Body Mass Index > 30
• Large breast volume requiring prostheses > 500ml
• Chronic pulmonary obstructive gold 4
• ASA (Physical Status score of American Society of Anesthesiologists) > 3
• Chronic shoulder pain on the side to operate, or both shoulders
• History of abarticular pathology of the shoulder on the operating side
• Patient involvment in another clinical research
• Protected patient or unable to give consent
• Pregnant or breastfeeding woman
• Vulnerable person (Article L1121-6 of the Public Health Code)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

implant for breast reconstruction

Experimental group

Description:

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

Treatment:

Procedure: Prophylactic mastectomy with immediate breast reconstruction