Trends of Mastectomy and Breast-Conserving Surgery in Female Breast Cancer Patients

December 5, 2018 updated by: Zuhoor K. AL-Sharif, King Abdulaziz University

Trends of Mastectomy and Breast-Conserving Surgery and Related Factors in Female Breast Cancer Patients Treated at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, 2009-2017

Breast cancer is the most common cancer in women across the world, accounting for 25.2% of cancer cases among females and 14.7% of cancer-related deaths among females worldwide. The survival rates are markedly lower in the developing countries compared to developed countries, as well as the age at diagnosis. Core management of breast cancer includes surgical removal of the tumor either by breast-conserving surgery (BCS) or mastectomy (removal of the whole breast). Choosing between these two procedures may be influenced by factors that have yet to be studied in Saudi Arabia. The investigators aimed to determine the prevalence of BCS and mastectomy and the factors that may influence the choice of procedure. This retrospective study was carried out by reviewing the records of female breast cancer patients who underwent BCS or mastectomy at King Abdulaziz University Hospital between 2009 to June 2017, excluding those with metastasis (distant spread of the cancer) or recurrence. Using frequencies for the rate, and multivariate tests, the investigators analyzed different demographic, clinicopathological, and radiological factors to detect correlations with procedure choice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Mecca
      • Jeddah, Mecca, Saudi Arabia, 00966
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female breast cancer patients who underwent surgery for breast cancer in King Abdulaziz University hospital between 2009 and June 2017 excluding those who had metastasis or recurrence before the surgery

Description

Inclusion Criteria:

  • Female, diagnosed with breast cancer, underwent surgery on the breast tumor in King Abdulaziz University Hospital

Exclusion Criteria:

  • Patients with metastatic breast cancer or recurrence of the cancer before the surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mastectomy
Procedure: Mastectomy
Removal of the whole breast
Breast-Conserving Surgery
Procedure: Breast-Conserving Surgery
Removal of the cancerous tissue only
Other Names:
  • Lumpectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of each of mastectomy and breast-conserving surgery
Time Frame: 2009-2017
The percentage of of patients who underwent each surgery
2009-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between the choice of procedure and the patients' age (in years)
Time Frame: 2009-2017
Statistical analysis using independent sample T-test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's size (in centimeters)
Time Frame: 2009-2017
Statistical analysis using independent sample T-test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and the tumor's receptor status (whether it is positive for estrogen, progesterone, and/or human epidermal growth factor receptor 2)
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017
The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings
Time Frame: 2009-2017
Statistical analysis using Chi-square test and binary logistic regression
2009-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2017

Primary Completion (Actual)

August 2, 2018

Study Completion (Actual)

August 2, 2018

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (Actual)

December 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 357-71

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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