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

Ain Shams University

Status: Completed

Conditions: Non Metastatic Breast Cancer

Treatments: Procedure: oncoplastic breast surgery; Procedure: Standard quadrantectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02901223

IRB0006379

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Quadrantectomy group

Active Comparator group

Description:

35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.

Treatment:

Procedure: Standard quadrantectomy

oncoplastic group

Active Comparator group

Description:

35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons.

Treatment:

Procedure: oncoplastic breast surgery