A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

October 3, 2016 updated by: Yasser Mohamed Abdel-samii, Ain Shams University

A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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:

  • 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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction assessed using questionnaire
Time Frame: two years
two 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)

August 1, 2013

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 2, 2016

First Submitted That Met QC Criteria

October 3, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 006379

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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