search
Back to results

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

Primary Purpose

Genetic Predisposition, Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prophylactic mastectomy with immediate breast reconstruction
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genetic Predisposition focused on measuring Prophylactic Surgical Procedure, Subcutaneous Mastectomy, Endoscopy, Breast Reconstruction, Breast Implants

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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)

Sites / Locations

  • Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

implant for breast reconstruction

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operative time
Duration of the prophylactic mastectomy with immediate breast reconstruction
Open surgery conversion rate
Open surgery conversion rate
Number of participants with an infection
Number of participants with early postoperative infection two months after the prophylactic mastectomy
Blood loss
Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
Number of participants with a local haematoma
Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction
Disunity of the scar
Number of patients with disunity of the scar after the prophylactic mastectomy
Exposure of the prosthesis
Number of patients with the prothesis exposed after the prophylactic mastectomy
Post-operative seromas after the prophylactic mastectomy
Number of patients with seromas 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
Skin case necrosis
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
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
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)
Hospital stay
The duration of hospitalization will be noted upon discharge from hospitalization
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.
Need for cosmetic reoperation
the need to use one or more lipomodelages
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.
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).

Full Information

First Posted
February 8, 2019
Last Updated
March 22, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Association la Montpellier Reine a du Cœur
search

1. Study Identification

Unique Protocol Identification Number
NCT03838549
Brief Title
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Acronym
MRIMOP
Official Title
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
October 22, 2024 (Anticipated)
Study Completion Date
October 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Association la Montpellier Reine a du Cœur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Predisposition, Breast Cancer
Keywords
Prophylactic Surgical Procedure, Subcutaneous Mastectomy, Endoscopy, Breast Reconstruction, Breast Implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gauthier Rathat, MD
Phone
0467336532
Email
g-rathat@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gauthier Rathat, MD
Phone
0467336532
Email
g.rathat@chu-montpellier.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs