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

Non Metastatic Breast Cancer Clinical Trial

Official title:

Oncoplastic Breast Surgery Allow Tumor Resection With More Oncological Safety Than Standard Quadrantectomy With Nice Cosmetic Results and Better Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02901223
• Other study ID #: IRB0006379
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: September 10, 2016
• Start date: September 2012
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non Metastatic Breast Cancer

Intervention

Procedure:
• Standard quadrantectomy
standard conservative surgery with no use of any plastic techniques
• oncoplastic breast surgery
Integration of plastic techniques with oncological procedures

Locations

Country	Name	City	State
Egypt	Yasser mohamed abdel-samii El Ghamrini	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Margins in all specimens measured in millimeters.		two years.	Yes
Primary	Patient satisfaction assessed using questionnaire.		Two years.	Yes