The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction

Study Overview
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Brief Summary
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The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

Detailed Description
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This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.

Official Title
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Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life

Conditions
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Non Metastatic Breast Cancer

Intervention / Treatment
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* Procedure: Standard quadrantectomy
* Procedure: oncoplastic breast surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 1, 2 breast cancer Non metastatic breast caner Singing informed consent Exclusion Criteria: Metastatic breast cancer Stage 3, 4 breast cancer Inflammatory breast cancer Multicentric/multifocal disease Ductal carcinoma in situ Patients older than 60 years History of breast surgery in oncoplastic group Co-morbidity in oncoplastic group Patients more than 60 years old

Ages Eligible for Study
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Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadrantectomy group<br>35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons. | Procedure: Standard quadrantectomy<br>* standard conservative surgery with no use of any plastic techniques<br>|
| Active Comparator: oncoplastic group<br>35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons. | Procedure: oncoplastic breast surgery<br>* Integration of plastic techniques with oncological procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margins in all specimens measured in millimeters. |  | two years. | 
| Patient satisfaction assessed using questionnaire. |  | Two years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncoplastic breast surgery, oncological safety, patient satisfaction