Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04640454
• Lead Sponsor: Alexandria University

Brief Summary

Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction. The study aimed to assess the oncological safety and aesthetic outcomes of nipple-sparing mastectomy and immediate breast reconstruction.

35 female patients with breast cancer were included in the study. The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Study First Posted: 2020-11-23
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• Diagnosis of ductal in situ carcinoma or infiltrating ductal carcinoma with a tumor diameter up to 3 cm
• Distance of the tumor from the nipple ≥ 2 cm
• Cancer or microcalcifications not localized in the central field.
• No blood secretions or other (nipple-areola complex) NAC disturbances
• Absence of skin involvement
• Indication to mastectomy for multifocal or diffuse microcalcifications
• Negative intraoperative assessment of NAC-bottom

Exclusion Criteria

• Tumor or microcalcifications localized in the central quadrant or in the retroareolar region
• Blood secretions or other NAC alterations
• Positive intraoperative assessment of NAC-bottom
• Inflammatory carcinoma
• Paget's disease of the nipple

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patients complications after nipple sparing mastectomy	2017-2019	Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints

Secondary Outcome Measures

Name	Time	Method
Aesthetic results assessed by Tzafetta et al scoring system	2017-2019

Trial Locations

Locations (1)

Alexandria faculty of medicine; 🇪🇬 Alexandria, Egypt