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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-01-01

Brief Summary

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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

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Conditions

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Breast Cancer

Keywords

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breast cancer mastectomy breast reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

28 Years

Maximum Eligible Age

68 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alexandria faculty of medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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13-27-10

Identifier Type: -

Identifier Source: org_study_id