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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
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, 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

Detailed Description:
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.

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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: 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 :
  1. Margins in all specimens measured in millimeters [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. 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:

  • 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

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Responsible Party: Yasser Mohamed Abdel-samii, Lecturer of General surgery, Ain Shams University
ClinicalTrials.gov Identifier: NCT02923635    
Other Study ID Numbers: 006379
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 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
Standard Wide Local Excision