Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
NCT Number: NCT06569706
Acronym: NEOMAMENDO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer
Interventions: PROCEDURE: Nipple-Sparing Mastectomy, with immediate breast reconstruction
Sponsor: University Hospital, Montpellier
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2029-09-30
Locations: Uhmontpellier, Montpellier, 34295, France

Summary:
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple. Endoscopic mastectomy is a technical alternative for small-volume breasts (cup sizes A, B, C), offering a NSM with IBR, but also concealing the scar on the axillary line. It can be performed with traditional laparoscopic equipment, making this technique much more accessible and less costly than robotic mastectomy. It uses a single-port device that is significantly less costly than robotic equipment.

Feasibility and safety studies remain limited to the Asian continent, and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal. This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center.

Primary Outcome Measures: Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients., The E-NSM 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., one day
Secondary Outcome Measures: Operative time, Duration of the prophylactic mastectomy with immediate breast reconstruction, one day|Hospital stay, The duration of hospitalization will be noted upon discharge from hospitalization, Through discharge from hospitalization, an average of 7 days|Open surgery conversion rate, Number of patients with open surgery conversion, one day|Oncologic safety of this approach, Evaluation of the early local recurrence of breast cancer rate at 1 and 2 year by imaging (breast ultrasound and/or MRI) and clinical examination.

Recurrence will be defined by an attenuating tissue mass on ultrasound and/or suspicious contrast on MRI and/or a clinically palpable nodule, that will be confirmed by biopsy with histological analysis., 1 and 2 years after surgery|Concealed nature of the breast scar, Number of patients with no visible scars, picture taken bare chest front and side after the surgery, Before surgery and 1 month and 3 months after surgery|Number of participants with an infection, Number of participants with postoperative infection after the mastectomy, including cases requiring implant replacement or removal., At surgery, and 1, 3, months after surgery|Skin case necrosis, The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if \> 25%, At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery|Complication rates (ischemia), Nipple-Areola-Complex (NAC) Ischemia: comparison with literature data on conventional surgery, including grading of ischemia, At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery|Number of participants with a local haematoma, Number of participants with a local haematoma caused by the mastectomy with immediate breast reconstruction requiring surgical intervention., At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery|Post-operative seromas, Number of patients with seromas after the mastectomy, At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery|Necrosis of areolo-nipple plaque, The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery., At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery|Aesthetic result, BREAST-Q© questionnaire Version 1.0 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/2023/01/BREAST-Q-BREAST-CANCER-USER-GUIDE.pdf for the response options., 90 days and 1 year after surgery|Life quality, Quality of life with an european quality of life scale (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, few problems, some problems, severe problems and extreme problems. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having few problems for 2, some problems for 3, severe problems for 4, and having extreme problems for 5. 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 55555 (having extreme problems in all dimensions)., Before surgery and 90 days and 1 year after surgery