A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

Breast Cancer Clinical Trial

Official title:

A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision:Margin Length and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923635
• Other study ID #: 006379
• Status: Completed
• Phase: N/A
• First received: October 2, 2016
• Last updated: October 3, 2016
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: October 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, and its impact on patient satisfaction.

Description:

This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

Recruitment information / eligibility

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

Eligibility

Inclusion Criteria:

• Patients with macromastia in oncoplastic group.

• Tumors >20% of breast volume in oncoplastic group.

• Young patients in oncoplastic group

• Tumors in medial or central quadrants in oncoplastic group

Exclusion Criteria:

• Patients >60 years.

• Patients with co-morbidities in oncoplastic group.

• Tumors >20% of breast volume in standard group.

• Tumors in medial or central quadrants in standard group

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Standard wide local excision.
Excision of breast cancer without integration of plastic technique
• oncoplastic breast surgery.
Integration of plastic techniques with oncological surgery for resection of breast cancer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

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