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Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries

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ClinicalTrials.gov Identifier: NCT04345081
Recruitment Status : Recruiting
First Posted : April 14, 2020
Last Update Posted : April 21, 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 delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM with standardized horizontal skin incision.

According to our hypothesis, SRNSM with standardized technique on pendulous/ ptotic breasts is a safe procedure compared to SSM. It also promotes the cosmetic efficacy of SRNSM with the removal of the entire glandular tissue through avoidance of the reduction of projection, the need later nipple reconstruction surgery and of areola tattoo.

In our study we propose that compared to one of the well-known and widely investigated studied SSM, our current standardized SRNSM technique is able to perform similar oncologically safe entire gland tissue removal, with low complication rate, accommodating for adjuvant treatments. Furthermore, it may provide superior cosmetic results than SSM (NAC is not removed, projection is maintained, and there is no need for further nipple reconstruction or tattoo) with high patient satisfaction which is maintained long term.


Condition or disease Intervention/treatment
Breast Cancer Mastectomy; Lymphedema Quality of Life Patient Satisfaction Procedure: Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction Procedure: Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Examining the Cosmetic Results and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy of Ptotic Breast Followed by Delayed-immediate Submuscular Implant Based- Breast Reconstruction Surgery, and Comparing it to Submuscular Delayed- Immediate Implant- Based Breast Reconstruction Procedures After Skin- Sparing Mastectomy. Response-adaptive, Prospective Randomized Clinical Trial
Actual Study Start Date : April 18, 2020
Estimated Primary Completion Date : April 5, 2022
Estimated Study Completion Date : April 5, 2027


Group/Cohort Intervention/treatment
SRNSM Group

Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstruction.

This Group receive Skin Reducing Nipple Sparing Mastectomy

Procedure: Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction
Skin Reducing Nipple Sparing Mastectomy is performed from Inverted T incisuion and nipple is preserved.

SSM Group

Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based reconstruction.

This Group receive Skin Sparing Mastectomy

Procedure: Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
Classic Skin- Sparing Mastectomy




Primary Outcome Measures :
  1. Oncological safety [ Time Frame: five years of follow-up ]
    Using correlation analysis to measure objective changes and the changes over time in oncological control achieved by different surgical techniques

  2. Patients' satisfaction [ Time Frame: five years of follow-up ]
    Using correlation analysis to measure objective changes and the changes over time in patients' satisfaction achieved by different surgical techniques

  3. Cosmetic results [ Time Frame: five years of follow-up ]
    Using correlation analysis to measure objective changes and the changes over time in cosmetic results achieved by different surgical techniques

  4. Quality of life [ Time Frame: five years of follow-up ]
    Using correlation analysis to measure objective changes and the changes over time in quality of life achieved by different surgical techniques


Secondary Outcome Measures :
  1. Complications rate [ Time Frame: five years of follow-up ]
    Based on the results of this study, the aim is to determine the rate of early and late postoperative complication.



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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
Sampling Method:   Non-Probability Sample
Study Population

The aim of the clinical study is to measure with a long-term follow-up and with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM. The planned subgroups contain 50-50 cases. Planned number of patients (calculated patients' number plus 10%): 50x2=100 +10 cases

  • 110 cases should be included.
Criteria

Inclusion Criteria:

  • Under the age of 65 with uni- or bilateral primary breast cancer ( clinical Stage 0-III), needing skin sparing mastectomy, nipple sparing mastectomy or patients require risk reducing mastectomy independently of the axillary surgery, having immediate or delayed-immediate implant based 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)
  • Mastectomy and 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

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): NCT04345081


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.         
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, et al. Principles and practice of oncoplastic breast surgery. Medicina Kiadó; 2019.

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Responsible Party: Dr. Zoltan Matrai, Head of Surgical Oncology, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT04345081    
Other Study ID Numbers: SRNSM
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 21, 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