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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640454
• Other study ID #: 13-27-10
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: November 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Gender: Female
• Age group: 28 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• nipple sparing mastectomy
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.

Locations

Country	Name	City	State
Egypt	Alexandria faculty of medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients complications after nipple sparing mastectomy	Complete general examination, local examination of the skin, nipple and areola were done to determine whether the patients suffered from any complaints	2017-2019
Secondary	Aesthetic results assessed by Tzafetta et al scoring system		2017-2019