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Completed

NCT Number: NCT03838549

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital

Montpellier, Hérault, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prophylactic mastectomy with immediate breast reconstruction

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Operative time

    Time frame: one day

    Duration of the prophylactic mastectomy with immediate breast reconstruction

  2. Open surgery conversion rate

    Time frame: one day

    Open surgery conversion rate

  3. 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

  4. Blood loss

    Time frame: one day

    Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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%

  11. 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.

  12. 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)

  13. Hospital stay

    Time frame: Through discharge from hospitalization, an average of 7 days

    The duration of hospitalization will be noted upon discharge from hospitalization

  14. 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.

  15. Need for cosmetic reoperation

    Time frame: 3 and 12 months after the prophylactic mastectomy

    the need to use one or more lipomodelages

  16. 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.

  17. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Association la Montpellier Reine a du Cœur

Registry information

Acronym: MRIMOP

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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