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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02901223
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Yasser Mohamed Abdel-samii, Ain Shams University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Metastatic Breast Cancer Procedure: Standard quadrantectomy Procedure: oncoplastic breast surgery Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life
Study Start Date : September 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Quadrantectomy group
35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.
Procedure: Standard quadrantectomy
standard conservative surgery with no use of any plastic techniques

Active Comparator: oncoplastic group
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
Integration of plastic techniques with oncological procedures




Primary Outcome Measures :
  1. Margins in all specimens measured in millimeters. [ Time Frame: two years. ]
  2. Patient satisfaction assessed using questionnaire. [ Time Frame: Two years. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901223


Locations
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Egypt
Yasser mohamed abdel-samii El Ghamrini
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Yasser Mohamed Abdel-samii, Lecturer of general surgery, Ain Shams University
ClinicalTrials.gov Identifier: NCT02901223    
Other Study ID Numbers: IRB0006379
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yasser Mohamed Abdel-samii, Ain Shams University:
Oncoplastic breast surgery
oncological safety
patient satisfaction