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Trial record 3 of 7 for:    mátrai zoltán | Hungary

Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques

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ClinicalTrials.gov Identifier: NCT04356235
Recruitment Status : Recruiting
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary

Brief Summary:

This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and/or silicone implant and/or Ultrapro mesh sling technique) over time.

According to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate.

This is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis on breast with mastopexy, significant volume increasement of the breast with mastopexy due to endocrine therapy, gradually progressive capsular contracture on the tumorous side, nipple flattening, nipple tattoo fading etc.) the two sides change differently resulting in significant asymmetry and consequently could lead to decreased patient satisfaction.

The high degree of asymmetry over time (which can be similar to the difference between the result of a simple mastectomy and natural breast (control group)), may indicates additional surgeries or usage of medical devices, putting a financial burden on the patient and the health system. On the other hand, the symmetry can be achieved with bilateral skin-sparing mastectomies and implant-based immediate or delayed-immediate reconstructions is clearly better and change less with time. The mastectomy of the contralateral disease-free side is considered as an unreasonable burden for moderate risk patients.

The information such as the need for multiple surgeries, change in symmetry over time etc., should be an important part of the professional decision-making mechanism and the surgeon should inform the patient during the primer surgery. Nowadays due to the lack of evidence-based knowledge, it is not part of the patient's information and surgical planning internationally. Planning breast units, attention, capacity and financial resources must also be provided to meet the long-term needs of patients who underwent postmastectomy breast reconstruction. Simple mastectomy with an external prosthesis can be an alternative for patients with intolerable degree of asymmetry or on the contrary, the results may justify the need for bilateral mastectomy and reconstruction even in the absence of high oncological risk and for purely symmetrical and cosmetic reasons.


Condition or disease Intervention/treatment
Mastectomy; Lymphedema Breast Cancer Quality of Life Procedure: A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction Procedure: B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling Procedure: C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation Procedure: D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation Procedure: E: unilateral simple mastectomy Procedure: F: after bilateral SSM, ASM, NSM, expander-implant exchange

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Study Type : Observational
Estimated Enrollment : 528 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examining and Comparing Patient Satisfaction and Long-term Cosmetic Results Achieved With Implant-based Breast Reconstruction Surgery With Submuscular Silicone Implant After Skin Sparing / Areola Sparing / Nipple Sparing Mastectomy and Contralateral Symmetrization (With Mastopexy and/or Silicone Implant and/or Ultrapro Mesh) With Unilateral Simple Mastectomies and With Bilateral Skin-sparing Mastectomies and Implant-based Immediate Breast Reconstructions. Response-adaptive Prospective Randomized, Comparative Clinical Trial
Estimated Study Start Date : April 27, 2020
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : April 10, 2027


Group/Cohort Intervention/treatment
A:Exp-impl-mastopexy
expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
Procedure: A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction

B: exp-impl-mastopexy+mesh
expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
Procedure: B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling

C: exp-impl-mastopexy+implant
expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
Procedure: C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation

D: exp-impl-mastopexy+implant+mesh
expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
Procedure: D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation

E: simple masectomy
unilateral simple mastectomy
Procedure: E: unilateral simple mastectomy
unilateral simple mastectomy

F: bilateral exp-impl
after bilateral SSM, ASM, NSM, expander-implant exchange
Procedure: F: after bilateral SSM, ASM, NSM, expander-implant exchange
after bilateral SSM, ASM, NSM, expander-implant exchange




Primary Outcome Measures :
  1. Quality of life: BREAST-Q validated questionnaire [ Time Frame: up to 5 years ]
    Correlation analysis of quality of life achieved by various surgical techniques. The quality of life is measured by BREAST-Q validated questionnaire. According to this, we give a score in a 1-100 scale measuring the variables of "psychosexual wellbeing" and "physical wellbeing". We use preoperatively a preoperative questionnaire and postoperatively a postoperative questionnaire. Higher rates show better quality of life. The questionnaires are filled before the procedure and after the surgery 4th-6th weeks then postoperatively in the 3rd months and every 6th months

  2. Patient satisfaction: BREAST-Q validated questionnaire [ Time Frame: up to 5 years ]
    Correlation analysis of patients' satisfaction achieved by various surgical techniques. The patients' satisfaction life is measured by BREAST-Q validated questionnaire. According to this, we give a score in a 1-100 scale measuring the variables of "satisfaction with the breast", "discomfort by radiotherapy" We use preoperatively a preoperative questionnaire and postoperatively a postoperative questionnaire. Higher rates show better patients' satisfaction. The questionnaires are filled before the procedure and after the surgery 4th-6th weeks then postoperatively in the 3rd months and every 6th months.


Secondary Outcome Measures :
  1. Objective cosmetic results [ Time Frame: up to 5 years ]
    To exclude subjectivity, the aesthetic results were classified objectively based on photo documentation using the Breast Cancer Conservative Treatment-cosmetic results (BCCT.core) software (version 20). The photo documentation performed the standard way in 5 position (antero-posterior (ap), 45 degree oblique and 90 degree lateral), in ap direction both ways arms up and down with strict adherence to personal privacy policies. BCCT.core software provides an extensive set of automated measurements using digital marks to establish a 4-point classification scale (excellent, good, fair and poor) and the overall assessment of cosmetic outcomes. Objective aesthetic results classified as fair or poor by the BCCT.core software were considered unacceptable. These numerical results can be statistically analyzed. The results are collected and averaged.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The aim of the study is to evaluate the time related cosmetic results in the subgroups of implant based postmastectomy reconstruction: mastopexy, mastopexy with Ultrapro sling technique, mastopexy with silicone implant and mastopexy with silicone implant and Ultrapro sling technique. The planned subgroups contain of 80-80 cases and the control group contains also 80 cases. Planned number of the patients (calculated patients number plus 10%): 80x6=480+ 48 cases ∑528 cases should be included.
Criteria

Inclusion Criteria:

  • Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing modern skin sparing mastectomy, nipple sparing mastectomy or areola sparing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstrucion on the ipsilateral side and symmetrisation on the contralateral side ( mastopexy and/or implant based reconstruction and/or breast sling with ultrapro mesh)
  • Control group: patients under 65 years with unilateral simplex mastectomy without breast reconstruction

Exclusion Criteria:

  • In case the patient does not volunteer for the examination or the follow-ups
  • Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without the tumorous disease
  • Malignant invasive tumor in the past history (except for non-melanoma skin tumors)
  • Mastectomyand reconstruction performed due pregnancy associated breast cancer
  • Prior breast surgery (e.g. aesthetic surgery, mastopexy) and/or radiotherapy on the breast or in the axilla
  • Malignant tumor is not removed completely with pathological examination
  • Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results
  • Autoimmune diseases
  • Mastitis carcinomatosa
  • Lymphangitis carcinomatosa
  • Open wound therapy due SSI
  • Long-term steroid usage, which changed the skin's quality and structure
  • Patient under foster care, or psychically non-cooperative patient
  • If breast correction performed during the 5 years follow up

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): NCT04356235


Locations
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Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Zoltan Matrai, M.D. Dr. med. habil, PhD    +3612248600 ext 3302    matraidoc@gmail.com   
Principal Investigator: Zoltan Matrai, M.D. Dr. Habil Ph.D. FEBS         
Sub-Investigator: Mihaly Ujhelyi, M.D. Ph.D. FEBS         
Sub-Investigator: Akos Savolt, M.D. Ph.D. FEBS         
Sub-Investigator: Peter Kelemen, M.D. FEBS         
Sub-Investigator: Orsolya Huszár, M.D.         
Sub-Investigator: Orsolya Ping, M.D.         
Sub-Investigator: Szilard Domjan, M.D.         
Sub-Investigator: Zsófia Jozsef, M.D.         
Sponsors and Collaborators
National Institute of Oncology, Hungary
Publications:
Weber WP, Haug M, Kurzeder C, Bjelic-Radisic V, Koller R, Reitsamer R, Fitzal F, Biazus J, Brenelli F, Urban C, Paulinelli RR, Blohmer JU, Heil J, Hoffmann J, Matrai Z, Catanuto G, Galimberti V, Gentilini O, Barry M, Hadar T, Allweis TM, Olsha O, Cardoso MJ, Gouveia PF, Rubio IT, de Boniface J, Svensjö T, Bucher S, Dubsky P, Farhadi J, Fehr MK, Fulco I, Ganz-Blättler U, Günthert A, Harder Y, Hauser N, Kappos EA, Knauer M, Landin J, Mechera R, Meani F, Montagna G, Ritter M, Saccilotto R, Schwab FD, Steffens D, Tausch C, Zeindler J, Soysal SD, Lohsiriwat V, Kovacs T, Tansley A, Wyld L, Romics L, El-Tamer M, Pusic AL, Sacchini V, Gnant M. Oncoplastic Breast Consortium consensus conference on nipple-sparing mastectomy. Breast Cancer Res Treat. 2018 Dec;172(3):523-537. doi: 10.1007/s10549-018-4937-1. Epub 2018 Sep 4. Review.
Mátrai Z, Gulyás G, Kovács T, Kásler M Principles and practice of oncoplastic breast surgery. Medicina Kiadó; 2019.

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Responsible Party: Dr. Zoltan Matrai, Head of Surgical Oncology Department, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT04356235    
Other Study ID Numbers: Ageing-NIO
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases