A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

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, and its impact on patient satisfaction.

Detailed Description
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This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

Official Title
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A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Standard wide local excision.
* Procedure: oncoplastic breast surgery.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with macromastia in oncoplastic group. Tumors >20% of breast volume in oncoplastic group. Young patients in oncoplastic group Tumors in medial or central quadrants in oncoplastic group Exclusion Criteria: Patients >60 years. Patients with co-morbidities in oncoplastic group. Tumors >20% of breast volume in standard group. Tumors in medial or central quadrants in standard group

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: Standard Wide Local Excision group<br>Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques . | Procedure: Standard wide local excision.<br>* Excision of breast cancer without integration of plastic technique<br>|
| Active Comparator: Oncoplastic group<br>Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures | Procedure: oncoplastic breast surgery.<br>* Integration of plastic techniques with oncological surgery for resection of breast cancer.<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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, Standard Wide Local Excision