CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Oncoplastic Approach Excisional Breast Biopsy +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02452333
NCT02452333N/ACompleted

Oncoplastic Approach to Excisional Breast Biopsies: A Prospective Randomized Controlled Trial

Akdeniz University·interventional·Posted May 22, 2015·Updated Feb 28, 2019

In Brief

A clinical study evaluating Oncoplastic Approach Excisional Breast Biopsy, Conventional Excisional Breast Biopsy, and 2 other interventions for Neoplasm of Female Breast and 3 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Many studies focusing on breast conserving surgery have affirmed the cosmetic effectiveness and oncologic success of oncoplastic methods and even modified variants of these methods reinforced with videoscopic applications. However, primary lumpectomy subjects in these studies are mainly patients who have already received the diagnosis of malignancy before the surgery. There is not much comprehensive work reported for patients without the diagnosis of malignancy. In this regard, the investigators believe the intent of the innovative oncoplastic intervention to the breast is underestimated in terms of providing diagnosis simultaneously constituting the basic component of surgical treatment. Thus, the purpose of this prospectively planned study is to provide and investigate the outcomes of an evidence-based oncoplastic approach algorithm for excisional breast biopsies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 22, 2015
Enrollment StartMay 1, 2015
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago

Interventions

Oncoplastic Approach Excisional Breast Biopsyprocedure

Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.

Conventional Excisional Breast Biopsyprocedure

Conventional Excisional Breast Biopsy

Tezel Method of Breast Volume Measurementother

Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle

Cosmetic Assessmentother

Cosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers.