Oncoplastic Approach to Excisional Breast Biopsies

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02452333
• Date of registration: 18/05/2015
• Prospective Registration: No
• Primary sponsor: Akdeniz University
• Public title: Oncoplastic Approach to Excisional Breast Biopsies
• Scientific title: Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial
• Date of first enrolment: May 2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02452333
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Turkey

Contacts

• Name: Cumhur Arici, Professor
• Affiliation: Akdeniz University, General Surgery Department

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who are decided to be suitable for excisional breast biopsy.

- Nonpalpable breast lesions suspicious for malignancy where less-invasive approach like
fine needle aspiration biopsy (FNA), core cutting needle (trucut) biopsy or
vacuum-assisted core biopsy can not provide sufficient diagnostic efficiency for the
diagnosis.

- Palpable breast lesions when a sufficiently precise diagnosis cannot be reached after
practicing less-invasive protocols.

Exclusion Criteria:

- Patients who are decided to be suitable for mastectomy included protocols as the
primary surgery.

- Patients who have previously had breast surgery.

- Patients who refused excisional breast biopsy.

- Patients who do not want to be photographed for cosmetic evaluations.

- Patients diagnosed with secondary suspicious breast lesions necessitating surgical
intervention during the follow-up period.

- Presence of probable multicentric lesions.

- Refusal of the patient to participate in the study for any reason.

- Aberrations in the normal development and involution of the breast

- Injury or trauma history of the breast resulted in deformity.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Diseases

Deformity of Reconstructed Breast

Neoplasm of Female Breast

Breast Neoplasms Diagnosis

Intervention(s)

Procedure: Conventional Excisional Breast Biopsy

Procedure: Oncoplastic Approach Excisional Breast Biopsy

Other: Cosmetic Assessment

Other: Tezel Method of Breast Volume Measurement

Primary Outcome(s)

Harris scale for the cosmetic result. [Time Frame: 3 months]

Secondary Outcome(s)

Morbidity [Time Frame: 3 months]

Radiologic assessment of surgical margins [Time Frame: Intraoperatively assessed]

Reoperations [Time Frame: 3 months]

Breast Size [Time Frame: Preoperatively assessed]

Anticipated specimen volume [Time Frame: Preoperatively assessed]

Exact specimen volume [Time Frame: Intraoperatively assessed]

Lesion Peripherality [Time Frame: Preoperatively assessed]

Surgical margin positivity for malignancy [Time Frame: Approximately 2 weeks]

Secondary ID(s)

70904504

Source(s) of Monetary Support

Please refer to primary and secondary sponsors