Actively Recruiting

Age: 18Years - 65Years
FEMALE
ID04345081

Examining Cosmetic Results and Patient Satisfaction of Skin Reducing Nipple Sparing Mastectomy Compared to Skin Sparing Mastectomy with Delayed-Immediate Implant-Based Breast Reconstruction

Led by National Institute of Oncology, Hungary · Updated on 2020-04-21

110

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the cosmetic outcomes, quality of life, and patient satisfaction between two types of breast reconstruction surgeries following mastectomy in women with breast cancer. It focuses on delayed-immediate breast reconstruction using Skin Reducing Nipple Sparing Mastectomy (SRNSM) and classic Skin Sparing Mastectomy (SSM). The study hypothesizes that SRNSM, especially in women with pendulous or ptotic breasts, may provide safe and superior cosmetic results with maintained nipple projection and less need for further nipple reconstruction or tattooing. Participants undergo either SRNSM or SSM, both followed by delayed-immediate implant-based breast reconstruction using standardized surgical techniques. SRNSM involves an inverted T incision with preservation of the nipple, while SSM is a classic skin-sparing procedure. The surgeries include removal of the entire glandular tissue and may involve axillary lymph node procedures if needed. The study observes these procedures under routine clinical protocols without altering oncological treatments. Participants are assessed before surgery and followed up for five years, with evaluations every 6 months after the initial postoperative checks. Assessments include photo documentation, body measurements, and completion of the BREAST-Q questionnaire to measure quality of life and satisfaction. Cosmetic results are also evaluated by independent breast surgeons using photographs. The study monitors oncological safety, patient satisfaction, cosmetic outcomes, quality of life, and complication rates over this long-term follow-up period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients under 65 years old
  • Diagnosed with uni- or bilateral primary breast cancer (clinical Stage 0-III)
  • Needing skin sparing mastectomy, nipple sparing mastectomy, or risk reducing mastectomy
  • Planned immediate or delayed-immediate implant-based breast reconstruction
Not Eligible

You will not qualify if you...

  • Not volunteering for examination or follow-ups
  • Age above 65 years or poor general health with life expectancy less than 2 years
  • History of malignant invasive tumor (except non-melanoma skin cancers)
  • Mastectomy and reconstruction due to pregnancy-associated breast cancer
  • Prior breast surgery (e.g., aesthetic surgery, mastopexy) or radiotherapy on breast or axilla
  • Incomplete removal of malignant tumor confirmed pathologically
  • Severe non-surgical complications affecting aesthetic or functional results
  • Autoimmune diseases
  • Mastitis carcinomatosa or lymphangitis carcinomatosa
  • Open wound therapy due to surgical site infection
  • Long-term steroid use altering skin quality
  • Patient under foster care or psychically non-cooperative patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Surgery day plus initial hospitalization period

Participants undergo either Skin Reducing Nipple Sparing Mastectomy or classic Skin Sparing Mastectomy followed by immediate or delayed-immediate implant-based breast reconstruction.

1 visit (surgery and hospitalization)

Post-operative Follow-up

Duration - Up to 5 years after surgery

Participants attend follow-up visits for body measurements, photo documentation, and quality of life assessments using questionnaires up to five years after surgery.

Visits at 4-6 weeks, 3 months, 6 months, then every 6 months up to 5 years

Trial Site Locations

Total: 1 location

1

National Institute of Oncology

Budapest, Hungary, 1122

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Patient satisfaction following nipple-sparing mastectomy and immediate breast reconstruction: an 8-year outcome study.

Risal Djohan, Earl Gage, James Gatherwright...

https://pubmed.ncbi.nlm.nih.gov/20195110

Highlights from the 15th St Gallen International Breast Cancer Conference 15-18 March, 2017, Vienna: tailored treatments for patients with early breast cancer.

Consuelo Morigi

https://pubmed.ncbi.nlm.nih.gov/28491135

Bipedicled Nipple-Sparing Mastectomy Versus Traditional Nipple-Sparing Mastectomy: Comparison of 2 Alternative Techniques in Order to Save Nipple-Areola Complex.

Giuseppe Falco, Annalisa Curcio, Francesco Marongiu...

https://pubmed.ncbi.nlm.nih.gov/31850968