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

Completed

• Conditions: Breast Neoplasms; Breast Cancer; Breast Cancer Female
• Interventions: Procedure: Breast-Conserving Surgery; Procedure: Mastectomy

• Registration Number: NCT03762642
• Lead Sponsor: King Abdulaziz University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-17
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Status Verified: 2018-12
• Study First Posted: 2018-12-04
• Last Update Submitted: 2018-12-05
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 335

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast-Conserving Surgery	Breast-Conserving Surgery	-
Mastectomy	Mastectomy	-

Primary Outcome Measures

Name	Time	Method
Prevalence of each of mastectomy and breast-conserving surgery	2009-2017	The percentage of of patients who underwent each surgery

Secondary Outcome Measures

Name	Time	Method
The relationship between the choice of procedure and the tumor's size (in centimeters)	2009-2017	Statistical analysis using independent sample T-test and binary logistic regression
The relationship between the choice of procedure and the tumor's stage (using the 7th "American Joint Committee on Cancer"'s staging guidelines)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and the tumor's histological grade (using the Nottingham Histologic Score system)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
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)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and the use of preoperative chemotherapy (also called "neoadjuvant chemotherapy")	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and the tumor's laterality (right versus left breast cancer)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and the tumor's focality (whether it is composed of more than one mass)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and the patients' age (in years)	2009-2017	Statistical analysis using independent sample T-test and binary logistic regression
The relationship between the choice of procedure and the tumor's centricity (whether it involves more than one quadrant of the breast)	2009-2017	Statistical analysis using Chi-square test and binary logistic regression
The relationship between the choice of procedure and having preoperative magnetic resonance imaging of the breast and its findings	2009-2017	Statistical analysis using Chi-square test and binary logistic regression

Trial Locations

Locations (1)

Faculty of Medicine; 🇸🇦 Jeddah, Mecca, Saudi Arabia