Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer

Alexandria University

Status: Unknown

Conditions: Breast Cancer

Treatments: Procedure: oncoplastic breast surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03900299

multifocal breast cancer2018

Details and patient eligibility

About

Multi-focal Breast Cancers(MFBC) still have undiscoverable Clinical Significance reflecting on a debatable surgical decision for this Category of breast cancer. A prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the Surgical Oncology Unit, Alexandria University from May. 2017 to May2018 and will be followed for 3 Years.Analysis will be done to settle a paradigm for surgical management of Multi-focal Breast Cancer

Full description

• Age at diagnosis: young patients are defined as younger than 35 years.
• Surgical techniques: Preoperatively all patients will undergo physical examination of both breasts and axillae as well as bilateral mammograms and ultrasonography of both breasts. Histopathological diagnosis of cancer will be made prior to surgery. The planned procedure will be discussed. Different oncoplastic techniques will be utilized to achieve oncologically appropriate margins with either sentinel lymph node detection or axillary lymph node dissection according to the triple assessment of the patients . Surgical margins were determined by macroscopic and histologic examination of frozen sections of the breast specimens in the operating room. An adequate safety margin of 1cm was always insured. Breast remodeling will be done according to breast size, degree of ptosis and size of defect.
• Tumor characteristics: size, nodal status, presence of lympho-vascular invasion, amount of intraductal component, tumor grade, margin status, hormone receptor, and Her2 neu status.
• Margins will be regarded as negative when permanent histological examination found no ink on the tumor.
• Postoperative surgical complications will be documented if happened; seroma formation, hematoma and or wound dehiscence.
• Cosmetic outcome: The postoperative esthetic result will be evaluated asking the patients to rate the postoperative cosmetic result and their degree of satisfaction compared to the preoperative breast using a five-point scale (excellent, 5; good, 4; fair, 3; poor, 2;bad, 1). Objective assessment of the cosmetic result was done by two surgeons, rated on a visual analog scale from 1 (unacceptable result) to 10 (excellent result). Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. (14)
• The occurrence of loco-regional recurrence or distant metastases during the follow-up period was recorded and considered as an end point for follow-up.

Enrollment: 114 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• all operable female patients affected with multifocal breast cancer

Exclusion criteria

• inflammatory breast cancer
• patients need receiving neoadjuvant therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

oncoplastic breast surgery

Other group

Treatment:

Procedure: oncoplastic breast surgery