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

Ain Shams University

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Standard wide local excision.; Procedure: oncoplastic breast surgery.

Study type: Interventional

Funder types: Other

Identifiers

NCT02923635

006379

Details and patient eligibility

About

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: Under 60 years old

Volunteers: No Healthy Volunteers

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

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

Standard Wide Local Excision group

Active Comparator group

Description:

Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .

Treatment:

Procedure: Standard wide local excision.

Oncoplastic group

Active Comparator group

Description:

Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

Treatment:

Procedure: oncoplastic breast surgery.