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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02901223

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Metastatic Breast Cancer	Procedure: Standard quadrantectomy Procedure: oncoplastic breast surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Quadrantectomy group 35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.	Procedure: Standard quadrantectomy standard conservative surgery with no use of any plastic techniques
Active Comparator: oncoplastic group 35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons.	Procedure: oncoplastic breast surgery Integration of plastic techniques with oncological procedures

Arm

Intervention/Treatment

Active Comparator: Quadrantectomy group

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

Procedure: Standard quadrantectomy

standard conservative surgery with no use of any plastic techniques

Active Comparator: oncoplastic group

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

Procedure: oncoplastic breast surgery

Integration of plastic techniques with oncological procedures

Outcome Measures

Primary Outcome Measures

Margins in all specimens measured in millimeters. [two years.]
Patient satisfaction assessed using questionnaire. [Two years.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 60 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yasser mohamed abdel-samii El Ghamrini	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasser Mohamed Abdel-samii, Lecturer of general surgery, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02901223

Other Study ID Numbers:

IRB0006379

First Posted:

Sep 15, 2016

Last Update Posted:

Sep 15, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Yasser Mohamed Abdel-samii, Lecturer of general surgery, Ain Shams University

Oncoplastic breast surgery

oncological safety

patient satisfaction

Study Results

No Results Posted as of Sep 15, 2016