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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

NCT04345081 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2020-04-21

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery

Classic Skin- Sparing Mastectomy

Sponsors & Collaborators

  • National Institute of Oncology, Hungary

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-18
Primary Completion
2022-04-05
Completion
2027-04-05

Countries

  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345081 on ClinicalTrials.gov