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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT03838549

Collaborator

Association la Montpellier Reine a du Cœur (Other)

Enrollment

Location

Arm

72.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Genetic Predisposition Breast Cancer	Procedure: Prophylactic mastectomy with immediate breast reconstruction	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 26, 2019

Anticipated Primary Completion Date :

Apr 23, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: implant for breast reconstruction 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	Procedure: Prophylactic mastectomy with immediate breast reconstruction It is an endoscopic approach for prophylactic mastectomy using an axillary single port

Arm

Intervention/Treatment

Experimental: implant for breast reconstruction

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

Procedure: Prophylactic mastectomy with immediate breast reconstruction

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

Outcome Measures

Primary Outcome Measures

success rate of total mastectomy [one day]
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.

Secondary Outcome Measures

Operative time [one day]
Duration of the prophylactic mastectomy with immediate breast reconstruction
Open surgery conversion rate [one day]
Open surgery conversion rate
Number of participants with an infection [1 and 3 months after the prophylactic mastectomy]
Number of participants with early postoperative infection two months after the prophylactic mastectomy
Blood loss [one day]
Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
Number of participants with a local haematoma [Between the day of the prophylactic mastectomy and a month later]
Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction
Disunity of the scar [1, 3, 6 and 12 months after the prophylactic mastectomy]
Number of patients with disunity of the scar after the prophylactic mastectomy
Exposure of the prosthesis [1, 3, 6 and 12 months after the prophylactic mastectomy]
Number of patients with the prothesis exposed after the prophylactic mastectomy
Post-operative seromas after the prophylactic mastectomy [1, 3, 6 and 12 months after the prophylactic mastectomy]
Number of patients with seromas after the prophylactic mastectomy
Complication rate of subcutaneous insufflation [3 and 12 months after the prophylactic mastectomy]
Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)> 45mmHg and refractory to ventilation ; second degree secondary burn
Skin case necrosis [1, 3, 6 and 12 months after the prophylactic mastectomy]
The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if > 25%
Necrosis of areolo-nipple plaque [1, 3, 6 and 12 months after the prophylactic mastectomy]
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
Analogue visual scale (EVA) [1, 3, 6 and 12 months after the prophylactic mastectomy]
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)
Hospital stay [Through discharge from hospitalization, an average of 7 days]
The duration of hospitalization will be noted upon discharge from hospitalization
Aesthetic result [3 and 12 months after the prophylactic mastectomy]
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.
Need for cosmetic reoperation [3 and 12 months after the prophylactic mastectomy]
the need to use one or more lipomodelages
Shoulder function [3 months after the prophylactic mastectomy]
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.
Life quality [3 and 12 months after the prophylactic mastectomy]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts 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