<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03838549</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0244</org_study_id>
    <secondary_id>UF 7672</secondary_id>
    <nct_id>NCT03838549</nct_id>
  </id_info>
  <brief_title>Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication</brief_title>
  <acronym>MRIMOP</acronym>
  <official_title>Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association la Montpellier Reine a du Cœur</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implant-based reconstruction is currently the most common choice for mastectomy&#xD;
      reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the&#xD;
      breast volume. Current techniques involve partial or total coverage of the implant with the&#xD;
      pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique&#xD;
      applied has functional and cosmetic consequences. In this study, an endoscopic approach will&#xD;
      be evaluated. This new surgical technique, using a single-port endoscopic way, will put the&#xD;
      scar is in the axillary area, away from the breast. The hypothesis is that this delocalized&#xD;
      scar potentially reduces the risk of exposure and allows placement of the implant in the&#xD;
      subcutaneous space, with no manipulation of the pectoralis major muscle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It s a practicability study, evaluating endoscopic approach for prophylactic mastectomy,&#xD;
      using an axillary single port. Classic open surgery conversion rate, operative time,&#xD;
      infectious rate, esthetical outcomes, and functional outcomes will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 26, 2019</start_date>
  <completion_date type="Anticipated">October 22, 2026</completion_date>
  <primary_completion_date type="Anticipated">October 22, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success rate of total mastectomy</measure>
    <time_frame>one day</time_frame>
    <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.&#xD;
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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>one day</time_frame>
    <description>Duration of the prophylactic mastectomy with immediate breast reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Open surgery conversion rate</measure>
    <time_frame>one day</time_frame>
    <description>Open surgery conversion rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with an infection</measure>
    <time_frame>1 and 3 months after the prophylactic mastectomy</time_frame>
    <description>Number of participants with early postoperative infection two months after the prophylactic mastectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss</measure>
    <time_frame>one day</time_frame>
    <description>Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a local haematoma</measure>
    <time_frame>Between the day of the prophylactic mastectomy and a month later</time_frame>
    <description>Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disunity of the scar</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <description>Number of patients with disunity of the scar after the prophylactic mastectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exposure of the prosthesis</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <description>Number of patients with the prothesis exposed after the prophylactic mastectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative seromas after the prophylactic mastectomy</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <description>Number of patients with seromas after the prophylactic mastectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate of subcutaneous insufflation</measure>
    <time_frame>3 and 12 months after the prophylactic mastectomy</time_frame>
    <description>Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)&gt; 45mmHg and refractory to ventilation ; second degree secondary burn</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin case necrosis</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <description>The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if &gt; 25%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrosis of areolo-nipple plaque</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <description>The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analogue visual scale (EVA)</measure>
    <time_frame>1, 3, 6 and 12 months after the prophylactic mastectomy</time_frame>
    <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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Through discharge from hospitalization, an average of 7 days</time_frame>
    <description>The duration of hospitalization will be noted upon discharge from hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aesthetic result</measure>
    <time_frame>3 and 12 months after the prophylactic mastectomy</time_frame>
    <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.&#xD;
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.&#xD;
Cf. https://qportfolio.org/wp-content/uploads/2020/BREAST-Q-USERS-GUIDE-V2.pdf for the response options.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for cosmetic reoperation</measure>
    <time_frame>3 and 12 months after the prophylactic mastectomy</time_frame>
    <description>the need to use one or more lipomodelages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder function</measure>
    <time_frame>3 months after the prophylactic mastectomy</time_frame>
    <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].&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>3 and 12 months after the prophylactic mastectomy</time_frame>
    <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).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Genetic Predisposition</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>implant for breast reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prophylactic mastectomy with immediate breast reconstruction</intervention_name>
    <description>It is an endoscopic approach for prophylactic mastectomy using an axillary single port</description>
    <arm_group_label>implant for breast reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk&#xD;
             factors for breast cancer)&#xD;
&#xD;
          -  Ask an immediate breast reconstruction during the surgery&#xD;
&#xD;
          -  World Heath Organization score &lt;3&#xD;
&#xD;
          -  Glandular volume : french bra cup size A, B ou C&#xD;
&#xD;
          -  Glandular ptosis &lt;=2 (Classification and Algorithm for Treatment of Breast Ptosis)&#xD;
&#xD;
          -  Contraception for woman of childbearing age and no pregnancy&#xD;
&#xD;
          -  Valid Social Security&#xD;
&#xD;
          -  Wrote consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of breast cancer surgery&#xD;
&#xD;
          -  Breast cancer not operated on the side concerned by the prophylactic mastectomy&#xD;
&#xD;
          -  Patient having had irradiant treatment&#xD;
&#xD;
          -  Breast hypertrophy&#xD;
&#xD;
          -  Smoking &gt; 10 cigarette/day&#xD;
&#xD;
          -  Body Mass Index &gt; 30&#xD;
&#xD;
          -  Large breast volume requiring prostheses &gt; 500ml&#xD;
&#xD;
          -  Chronic pulmonary obstructive gold 4&#xD;
&#xD;
          -  ASA (Physical Status score of American Society of Anesthesiologists) &gt; 3&#xD;
&#xD;
          -  Chronic shoulder pain on the side to operate, or both shoulders&#xD;
&#xD;
          -  History of abarticular pathology of the shoulder on the operating side&#xD;
&#xD;
          -  Patient involvment in another clinical research&#xD;
&#xD;
          -  Protected patient or unable to give consent&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Vulnerable person (Article L1121-6 of the Public Health Code)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gauthier Rathat, MD</last_name>
    <phone>0467336532</phone>
    <email>g-rathat@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <state>Hérault</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gauthier Rathat, MD</last_name>
      <phone>0467336532</phone>
      <email>g.rathat@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prophylactic Surgical Procedure</keyword>
  <keyword>Subcutaneous Mastectomy</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Breast Reconstruction</keyword>
  <keyword>Breast Implants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genetic Predisposition to Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03838549
org study id: RECHMPL18_0244
secondary id: UF 7672
nct id: NCT03838549
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: success rate of total mastectomy
time frame: one day
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
measure: Operative time
time frame: one day
description: Duration of the prophylactic mastectomy with immediate breast reconstruction
measure: Open surgery conversion rate
time frame: one day
description: Open surgery conversion rate
measure: Number of participants with an infection
time frame: 1 and 3 months after the prophylactic mastectomy
description: Number of participants with early postoperative infection two months after the prophylactic mastectomy
measure: Blood loss
time frame: one day
description: Blood loss (milliliters) during the prophylactic mastectomy with immediate breast reconstruction
measure: Number of participants with a local haematoma
time frame: Between the day of the prophylactic mastectomy and a month later
description: Number of participants with a local haematoma caused by the prophylactic mastectomy with immediate breast reconstruction
measure: Disunity of the scar
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
description: Number of patients with disunity of the scar after the prophylactic mastectomy
measure: Exposure of the prosthesis
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
description: Number of patients with the prothesis exposed after the prophylactic mastectomy
measure: Post-operative seromas after the prophylactic mastectomy
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
description: Number of patients with seromas after the prophylactic mastectomy
measure: Complication rate of subcutaneous insufflation
time frame: 3 and 12 months after the prophylactic mastectomy
description: Refractory induced hypercapnia: EtCO2 (expired fraction of CO2)> 45mmHg and refractory to ventilation ; second degree secondary burn
measure: Skin case necrosis
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
description: The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if > 25%
measure: Necrosis of areolo-nipple plaque
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
description: The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
measure: Analogue visual scale (EVA)
time frame: 1, 3, 6 and 12 months after the prophylactic mastectomy
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)
measure: Hospital stay
time frame: Through discharge from hospitalization, an average of 7 days
description: The duration of hospitalization will be noted upon discharge from hospitalization
measure: Aesthetic result
time frame: 3 and 12 months after the prophylactic mastectomy
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.
measure: Need for cosmetic reoperation
time frame: 3 and 12 months after the prophylactic mastectomy
description: the need to use one or more lipomodelages
measure: Shoulder function
time frame: 3 months after the prophylactic mastectomy
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.
measure: Life quality
time frame: 3 and 12 months after the prophylactic mastectomy
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).
arm group label: implant for breast reconstruction
arm group type: Experimental
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: Prophylactic mastectomy with immediate breast reconstruction
description: It is an endoscopic approach for prophylactic mastectomy using an axillary single port
arm group label: implant for breast reconstruction
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Gauthier Rathat, MD
phone: 0467336532
email: g-rathat@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Genetic Predisposition to Disease