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

Not Applicable

Completed

• Conditions: Breastcancer
• Interventions: Procedure: Oncoplastic breast surgery; Procedure: Standard conservative breast surgery

• Registration Number: NCT03012152
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2012-09
• Primary Completion: 2013-05
• Study Completion: 2016-09
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

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

Inclusion Criteria

• Female Patients with stage 1,2 breast cancer.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Margins in all specimens measured in millimeters 2.	2 years