The Impact of Oncoplastic Breast Surgery on the Oncological Safety and Patient Satisfaction

Not Applicable

Completed

• Conditions: Non Metastatic Breast Cancer
• Interventions: Procedure: Standard quadrantectomy; Procedure: oncoplastic breast surgery

• Registration Number: NCT02901223
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

Detailed Description

This non randomized prospective trial was conducted on 70 female patients presented to our tertiary referral breast unit -Ain Shams University hospitals with non metastatic breast cancer during the period from September 2012 to September 2013. All of them signed an informed consent to share in this study that was approved in the ethical committee held on April 2012 - Ain Shams University. Our patients were divided into 2 equal groups: group A (35patients) who underwent standard quadrantectomy, group B (35 patients) who underwent oncoplastic surgery. In group A all quadrantectomies were done by general breast surgeons while in group B the oncoplastic procedures were done by well trained oncoplastic breast surgeons not assisted by plastic surgeons. The following data were reported in all cases including: age, family history, tumor size, volume and weight of the specimen, location of tumor, margin length, (primary tumor, regional nodes, metastasis) staging, molecular subtype and patient satisfaction.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-09
• Study Completion: 2016-05
• Study First Submitted: 2016-08-31
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-10
• Last Update Submitted: 2016-09-10
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

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

Inclusion Criteria

• Stage 1, 2 breast cancer
• Non metastatic breast caner
• Singing informed consent

Exclusion Criteria

• Metastatic breast cancer
• Stage 3, 4 breast cancer
• Inflammatory breast cancer
• Multicentric/multifocal disease
• Ductal carcinoma in situ
• Patients older than 60 years
• History of breast surgery in oncoplastic group
• Co-morbidity in oncoplastic group
• Patients more than 60 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadrantectomy group	Standard quadrantectomy	35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.
oncoplastic group	oncoplastic breast surgery	35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons.

Primary Outcome Measures

Name	Time	Method
Margins in all specimens measured in millimeters.	two years.
Patient satisfaction assessed using questionnaire.	Two years.

Trial Locations

Locations (1)

Yasser mohamed abdel-samii El Ghamrini; 🇪🇬 Cairo, Egypt