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

NCT04640454 | Completed DMC

• 1 other identifier: 13-27-10
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; mastectomy; breast reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Aesthetic results assessed by Tzafetta et al scoring system

  2017-2019

Interventions

nipple sparing mastectomy PROCEDURE

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.

Eligibility Criteria

• Age: 28 Years - 68 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The mean age of the studied patients was 44.00±9.47 years old; the youngest patient was 28 years old and the oldest one was 68 years old, the majority of patients were 40-50 years of age (54%) As regard the patients' marital status; 31 patients were married constituting 88.57 % and only 4 (11.4 %) patients were single The main complaint of 25 of them (71.42%) was painless breast lump while 8 cases (22.85%) presented with local recurrence after previous breast conservative surgery and only two case (5.7%) presented by extensive mammographic calcifications on screening mammography

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria faculty of medicine

Alexandria, 21500, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 23, 2020
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

EG (1)