A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction

January 4, 2017 updated by: Yasser Mohamed Abdel-samii, Ain Shams University

A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females

This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Patients with stage 1,2 breast cancer.

Exclusion Criteria:

  • Patients >60 years.
  • Patients with previous breast surgery.
  • patients candidate for mastectomy or palliative excision. Patients with collagen disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard conservative group

Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .

.
Procedure: Standard conservative breast surgery
Active Comparator: Oncoplastic group
Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures
Procedure: Oncoplastic breast surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Margins in all specimens measured in millimeters 2.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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