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

NCT04345081 | Recruiting

• 1 other identifier: SRNSM
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Mastectomy; Lymphedema; Quality of Life; Patient Satisfaction

Outcome Measures

Primary Outcomes (4)

• Oncological safety

  Using correlation analysis to measure objective changes and the changes over time in oncological control achieved by different surgical techniques

  five years of follow-up

• Patients' satisfaction

  Using correlation analysis to measure objective changes and the changes over time in patients' satisfaction achieved by different surgical techniques

  five years of follow-up

• Cosmetic results

  Using correlation analysis to measure objective changes and the changes over time in cosmetic results achieved by different surgical techniques

  five years of follow-up

• Quality of life

  Using correlation analysis to measure objective changes and the changes over time in quality of life achieved by different surgical techniques

  five years of follow-up

Secondary Outcomes (1)

• Complications rate

  five years of follow-up

Study Arms (2)

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

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

Interventions

Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction PROCEDURE

Skin Reducing Nipple Sparing Mastectomy is performed from Inverted T incisuion and nipple is preserved.

SRNSM Group

Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery PROCEDURE

Classic Skin- Sparing Mastectomy

SSM Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Oncology, Hungary: lead

Study Sites (1)

National Institute of Oncology

Budapest, 1122, Hungary

RECRUITING

Related Publications (15)

• Galimberti V, Vicini E, Corso G, Morigi C, Fontana S, Sacchini V, Veronesi P. Nipple-sparing and skin-sparing mastectomy: Review of aims, oncological safety and contraindications. Breast. 2017 Aug;34 Suppl 1(Suppl 1):S82-S84. doi: 10.1016/j.breast.2017.06.034. Epub 2017 Jun 30.

  PMID: 28673535 BACKGROUND

• Murthy V, Chamberlain RS. Defining a place for nipple sparing mastectomy in modern breast care: an evidence based review. Breast J. 2013 Nov-Dec;19(6):571-81. doi: 10.1111/j.1524-4741.2011.01220.x. Epub 2012 Jan 29.

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  PMID: 30182349 BACKGROUND

• Rowland JH, Desmond KA, Meyerowitz BE, Belin TR, Wyatt GE, Ganz PA. Role of breast reconstructive surgery in physical and emotional outcomes among breast cancer survivors. J Natl Cancer Inst. 2000 Sep 6;92(17):1422-9. doi: 10.1093/jnci/92.17.1422.

  PMID: 10974078 BACKGROUND

• Fang SY, Shu BC, Chang YJ. The effect of breast reconstruction surgery on body image among women after mastectomy: a meta-analysis. Breast Cancer Res Treat. 2013 Jan;137(1):13-21. doi: 10.1007/s10549-012-2349-1. Epub 2012 Dec 6.

  PMID: 23225142 BACKGROUND

• Djohan R, Gage E, Gatherwright J, Pavri S, Firouz J, Bernard S, Yetman R. Patient satisfaction following nipple-sparing mastectomy and immediate breast reconstruction: an 8-year outcome study. Plast Reconstr Surg. 2010 Mar;125(3):818-29. doi: 10.1097/PRS.0b013e3181ccdaa4.

  PMID: 20195110 BACKGROUND

• Morigi C. Highlights from the 15th St Gallen International Breast Cancer Conference 15-18 March, 2017, Vienna: tailored treatments for patients with early breast cancer. Ecancermedicalscience. 2017 Apr 7;11:732. doi: 10.3332/ecancer.2017.732. eCollection 2017.

  PMID: 28491135 BACKGROUND

• Kontos M, Lanitis S, Constantinidou A, Sakarellos P, Vagios E, Tampaki EC, Tampakis A, Fragoulis M. Nipple-sparing skin-reducing mastectomy with reconstruction for large ptotic breasts. J Plast Reconstr Aesthet Surg. 2020 Apr;73(4):690-695. doi: 10.1016/j.bjps.2019.11.025. Epub 2019 Nov 28.

  PMID: 31928958 BACKGROUND

• Falco G, Curcio A, Marongiu F, Buggi F, Mingozzi M, Mele S, Ferrari G, Folli S. Bipedicled Nipple-Sparing Mastectomy Versus Traditional Nipple-Sparing Mastectomy: Comparison of 2 Alternative Techniques in Order to Save Nipple-Areola Complex. Ann Plast Surg. 2020 Apr;84(4):366-374. doi: 10.1097/SAP.0000000000002166.

  PMID: 31850968 BACKGROUND

• Rosenberger WF, Sverdlov O, Hu F. Adaptive randomization for clinical trials. J Biopharm Stat. 2012;22(4):719-36. doi: 10.1080/10543406.2012.676535.

  PMID: 22651111 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

  PMID: 19644246 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

• Dikmans REG, Nene LEH, Bouman MB, de Vet HCW, Mureau MAM, Buncamper ME, Winters HAH, Ritt MJPF, Mullender MG. The Aesthetic Items Scale: A Tool for the Evaluation of Aesthetic Outcome after Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Mar 1;5(3):e1254. doi: 10.1097/GOX.0000000000001254. eCollection 2017 Mar.

  PMID: 28458968 BACKGROUND

• Mátrai Z, Gulyás G, Kovács T, et al. Principles and practice of oncoplastic breast surgery. Medicina Kiadó; 2019.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Surgical Oncology

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 14, 2020
• Study Start: April 18, 2020
• Primary Completion: April 5, 2022
• Study Completion (Estimated): April 5, 2027
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)