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Completed

NCT Number: NCT02923635

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard wide local excision.

Procedure

Excision of breast cancer without integration of plastic technique

oncoplastic breast surgery.

Procedure

Integration of plastic techniques with oncological surgery for resection of breast cancer.

Primary outcomes

  1. Margins in all specimens measured in millimeters

    Time frame: Two years

Secondary outcomes

  1. Patient satisfaction assessed using questionnaire

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Oct 4, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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