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

NCT ID: NCT02901223

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-05-31

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.

Conditions

Non Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quadrantectomy group

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

Group Type: ACTIVE_COMPARATOR

Standard quadrantectomy

Intervention Type: PROCEDURE

standard conservative surgery with no use of any plastic techniques

oncoplastic group

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

Group Type: ACTIVE_COMPARATOR

oncoplastic breast surgery

Intervention Type: PROCEDURE

Integration of plastic techniques with oncological procedures

Interventions

Standard quadrantectomy

standard conservative surgery with no use of any plastic techniques

Intervention Type: PROCEDURE

oncoplastic breast surgery

Integration of plastic techniques with oncological procedures

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Yasser Mohamed Abdel-samii

Lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yasser mohamed abdel-samii El Ghamrini

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB0006379

Identifier Type: -

Identifier Source: org_study_id