Clinical trial · Observational
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy; Lymphedema | — | UNRESOLVED | — |
| Patient Satisfaction | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction | Procedure | — | UNRESOLVED |
| Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SRNSM Group
- description
- 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
- interventionNames
- Procedure: Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction
- label
- SSM Group
- description
- 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
- interventionNames
- Procedure: Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDGalimberti 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
- BACKGROUNDMurthy 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. PMID 22284266
- BACKGROUNDWeber 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, Svensjo T, Bucher S, Dubsky P, Farhadi J, Fehr MK, Fulco I, Ganz-Blattler U, Gunthert 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. PMID 30182349
- BACKGROUNDRowland 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
- BACKGROUNDFang 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
- BACKGROUNDDjohan 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.