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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Standard wide local excision.; Procedure: oncoplastic breast surgery.

• Registration Number: NCT02923635
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09
• Primary Completion: 2013-08
• Study Completion: 2016-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-02
• Study First Submitted QC: 2016-10-03
• Last Update Submitted: 2016-10-03
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Wide Local Excision group	Standard wide local excision.	Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .
Oncoplastic group	oncoplastic breast surgery.	Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

Primary Outcome Measures

Name	Time	Method
Margins in all specimens measured in millimeters	Two years

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction assessed using questionnaire	two years