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

April 21, 2026 updated by: University Hospital, Montpellier
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

Completed

Conditions

Intervention / Treatment

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 (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.

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
Time Frame: one day
Duration of the prophylactic mastectomy with immediate breast reconstruction
one day
Open surgery conversion rate
Time Frame: one day
Open surgery conversion rate
one day
Number of participants with an infection
Time Frame: 1 and 3 months after the prophylactic mastectomy
Number of participants with early postoperative infection two months after the prophylactic mastectomy
1 and 3 months after the prophylactic mastectomy
Blood loss
Time Frame: one day
Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
one day
Number of participants with a local haematoma
Time Frame: 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
Between the day of the prophylactic mastectomy and a month later
Disunity of the scar
Time Frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
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
Time Frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
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
Time Frame: 1, 3, 6 and 12 months 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
Time Frame: 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
3 and 12 months after the prophylactic mastectomy
Skin case necrosis
Time Frame: 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%
1, 3, 6 and 12 months after the prophylactic mastectomy
Necrosis of areolo-nipple plaque
Time Frame: 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.
1, 3, 6 and 12 months after the prophylactic mastectomy
Analogue visual scale (EVA)
Time Frame: 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)
1, 3, 6 and 12 months after the prophylactic mastectomy
Hospital stay
Time Frame: Through discharge from hospitalization, an average of 7 days
The duration of hospitalization will be noted upon discharge from hospitalization
Through discharge from hospitalization, an average of 7 days
Aesthetic result
Time Frame: 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.
3 and 12 months after the prophylactic mastectomy
Need for cosmetic reoperation
Time Frame: 3 and 12 months after the prophylactic mastectomy
the need to use one or more lipomodelages
3 and 12 months after the prophylactic mastectomy
Shoulder function
Time Frame: 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.
3 months after the prophylactic mastectomy
Life quality
Time Frame: 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).
3 and 12 months after the prophylactic mastectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Association la Montpellier Reine a du Cœur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2019

Primary Completion (Actual)

September 26, 2025

Study Completion (Actual)

September 26, 2025

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)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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