A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision
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|ClinicalTrials.gov Identifier: NCT02923635|
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Ain Shams University
Information provided by (Responsible Party):
Yasser Mohamed Abdel-samii, Ain Shams University
The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Standard wide local excision. Procedure: oncoplastic breast surgery.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||June 2016|
Active Comparator: Standard Wide Local Excision group
Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .
Procedure: Standard wide local excision.
Excision of breast cancer without integration of plastic technique
Active Comparator: Oncoplastic group
Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures
Procedure: oncoplastic breast surgery.
Integration of plastic techniques with oncological surgery for resection of breast cancer.
Primary Outcome Measures :
- Margins in all specimens measured in millimeters [ Time Frame: Two years ]
Secondary Outcome Measures :
- Patient satisfaction assessed using questionnaire [ Time Frame: two years ]
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