<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03012152</url>
  </required_header>
  <id_info>
    <org_study_id>16379</org_study_id>
    <nct_id>NCT03012152</nct_id>
  </id_info>
  <brief_title>A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction</brief_title>
  <official_title>A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This non randomized study is a comparative study between standard conservative breast surgery&#xD;
      and oncoplastic surgery as regard margin status and patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This planned study was conducted on 70 female patients presented to our tertiary referral&#xD;
      breast unit at Ain Shams University hospitals with breast cancer amid the period from&#xD;
      September 2012 to May 2013 .&#xD;
&#xD;
      Every one of them signed an informed consent to partake in this study that was approved in a&#xD;
      meeting held by the ethical committee on august 2012 at Ain Shams University. All patients&#xD;
      sharing in the study received closed envelope before surgery in a randomized way in which the&#xD;
      surgical technique is written either standard conservative surgery or oncoplastic&#xD;
      surgery(Double Blind).&#xD;
&#xD;
      Our patients were partitioned into 2 equal groups: group A (35patients) who underwent&#xD;
      standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Margins in all specimens measured in millimeters 2.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>Standard conservative group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .&#xD;
.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oncoplastic group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard conservative breast surgery</intervention_name>
    <arm_group_label>Standard conservative group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oncoplastic breast surgery</intervention_name>
    <arm_group_label>Oncoplastic group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Patients with stage 1,2 breast cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;60 years.&#xD;
&#xD;
          -  Patients with previous breast surgery.&#xD;
&#xD;
          -  patients candidate for mastectomy or palliative excision. Patients with collagen&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Yasser Mohamed Abdel-samii</investigator_full_name>
    <investigator_title>Lecturer of General surgery</investigator_title>
  </responsible_party>
  <keyword>Oncoplastic surgery</keyword>
  <keyword>Standard conservative surgery</keyword>
  <keyword>Patient satisfaction</keyword>
  <keyword>Margin Status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012152
org study id: 16379
nct id: NCT03012152
lead sponsor: 
has dmc: Yes
This non randomized study is a comparative study between standard conservative breast surgery
      and oncoplastic surgery as regard margin status and patient satisfaction.
This planned study was conducted on 70 female patients presented to our tertiary referral
      breast unit at Ain Shams University hospitals with breast cancer amid the period from
      September 2012 to May 2013 .

      Every one of them signed an informed consent to partake in this study that was approved in a
      meeting held by the ethical committee on august 2012 at Ain Shams University. All patients
      sharing in the study received closed envelope before surgery in a randomized way in which the
      surgical technique is written either standard conservative surgery or oncoplastic
      surgery(Double Blind).

      Our patients were partitioned into 2 equal groups: group A (35patients) who underwent
      standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Margins in all specimens measured in millimeters 2.
time frame: 2 years
arm group label: Standard conservative group
arm group type: Active Comparator
description: Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .
.
arm group label: Oncoplastic group
arm group type: Active Comparator
description: Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures
intervention type: Procedure
intervention name: Standard conservative breast surgery
arm group label: Standard conservative group
intervention type: Procedure
intervention name: Oncoplastic breast surgery
arm group label: Oncoplastic group
criteria: 
gender: Female
minimum age: N/A
maximum age: 60 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Yasser Mohamed Abdel-samii
investigator title: Lecturer of General surgery
mesh term: Breast Neoplasms
sharing ipd: Undecided