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

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ClinicalTrials.gov Identifier: NCT03838549
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
association la montpellier reine a du coeur
Information provided by (Responsible Party):
University Hospital, Montpellier

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 Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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: 2 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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Genetic risk factors for breast cancer
  • Ask for prophylactic mastectomy
  • World Heath Organization score <3
  • Glandular volume : bonnets A, B ou C
  • Glandular ptosis <=2 (Classification and Algorithm for Treatment of Breast Ptosis)
  • Contraception
  • No pregnancy
  • Valid Social Security
  • Wrote consent

Exclusion Criteria:

  • History of breast cancer surgery
  • Breast cancer not operated
  • Patient with irradiant treatment
  • Breast hypertrophy
  • Smoking > 10 cigarette/day
  • obesity
  • Large breast volume requiring prostheses > 500ml
  • Chronic pulmonary obstructive gold 4
  • Chronic shoulder pain on the side to operate, or both shoulders
  • history of abarticular pathology of the shoulder on the operating side

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838549


Contacts
Contact: Gauthier Rathat, MD 0467336532 g-rathat@chu-montpellier.fr

Locations
France
Montpellier University Hospital Not yet recruiting
Montpellier, Hérault, France, 34295
Contact: Gauthier Rathat, MD    0467336532    g.rathat@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
association la montpellier reine a du coeur

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03838549     History of Changes
Other Study ID Numbers: RECHMPL18_0244 UF 7672
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Prophylactic Surgical Procedure
Subcutaneous Mastectomy
Endoscopy
Breast Reconstruction
Breast Implants

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes