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Completed

NCT Number: NCT02901223

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

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.

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Key information

Conditions

Non Metastatic Breast Cancer Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

Up to 60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yasser mohamed abdel-samii El Ghamrini

Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard quadrantectomy

Procedure

standard conservative surgery with no use of any plastic techniques

oncoplastic breast surgery

Procedure

Integration of plastic techniques with oncological procedures

Primary outcomes

  1. Margins in all specimens measured in millimeters.

    Time frame: two years.

  2. Patient satisfaction assessed using questionnaire.

    Time frame: Two years.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2016
First posted
Sep 15, 2016
Registry last updated
Sep 15, 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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