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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Wide Local Excision group

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

Group Type ACTIVE_COMPARATOR

Standard wide local excision.

Intervention Type PROCEDURE

Excision of breast cancer without integration of plastic technique

Oncoplastic group

Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

Group Type ACTIVE_COMPARATOR

oncoplastic breast surgery.

Intervention Type PROCEDURE

Integration of plastic techniques with oncological surgery for resection of breast cancer.

Interventions

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Standard wide local excision.

Excision of breast cancer without integration of plastic technique

Intervention Type PROCEDURE

oncoplastic breast surgery.

Integration of plastic techniques with oncological surgery for resection of breast cancer.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No