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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Genetic Predisposition
• Intervention / Treatment: Procedure: Prophylactic mastectomy with immediate breast reconstruction

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gauthier Rathat, MD; Phone Number: 0467336532; Email: g-rathat@chu-montpellier.fr

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34295
      • Recruiting
      • Montpellier University Hospital
      • Contact: Gauthier Rathat, MD; Phone Number: 0467336532; Email: g.rathat@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Duration of the prophylactic mastectomy with immediate breast reconstruction	one day
Open surgery conversion rate	Open surgery conversion rate	one day
Number of participants with an infection	Number of participants with early postoperative infection two months after the prophylactic mastectomy	1 and 3 months after the prophylactic mastectomy
Blood loss	Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction	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	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	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	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	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	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%	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.	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)	1, 3, 6 and 12 months after the prophylactic mastectomy
Hospital stay	The duration of hospitalization will be noted upon discharge from hospitalization	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.	3 and 12 months after the prophylactic mastectomy
Need for cosmetic reoperation	the need to use one or more lipomodelages	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.	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).	3 and 12 months after the prophylactic mastectomy

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Association la Montpellier Reine a du Cœur

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Anticipated): October 22, 2024
• Study Completion (Anticipated): October 22, 2026

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Endoscopy; Breast Reconstruction; Prophylactic Surgical Procedure; Subcutaneous Mastectomy; Breast Implants
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: RECHMPL18_0244; UF 7672 (Other Identifier: UH Montpellier)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No