Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06026176 |
| Other study ID # |
IRC/2433/022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
B.P. Koirala Institute of Health Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD
AT BPKIHS
Rationale: The Study will help us to know about pattern of presentation of different breast
diseases
Aims and Objectives:
1. To investigate the pattern of symptoms in patients with Breast diseases
2. To assess the burden of different Breast diseases. Research Hypothesis (if relevant):
N/A
1. Material & Methods:
1. Whether study involves Human/animals or both : Human
2. Population/ participants: Files of patients presenting in Surgical OPD with Breast
related complaints
3. Type of study design: : Descriptive Research Design
4. Human study :
Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related
complaints Exclusion Criteria: Those who deny consent for participation.
5. Expected sample size : 823 Sample size calculation: Mentioned in methodology
6. Control groups : N/A
7. Probable duration of study: 365 days
8. Setting: Outpatient Department
9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic
characteristics such as age, gender, address. ii. Family History
Dependent Variables:
i. Clinical symptoms associated with breast disease ii. Type of breast disease (benign or
malignant)
Outcome measures:
Primary (main outcome): All dependent variables
(i) Rational for statistical methods to be employed : Retrospective Study Data will be
entered in Microsoft Excel and converted it into SPSS for statistical analysis For
descriptive studies, percentage, ratio, mean, SD, median will be calculated along with
graphical and tabular presentations.
For inferential statistics, bivariate analysis will be done using χ2 test and independent t
test to find out the significant differences between dependent and independent variables at
95% confidence interval and p-value significant at <0.05. Multivariate logistic regression
will be done to adjust for confounding.
(ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical
Research Protocol Review Board (UM-RPRB) of BPKIHS.
(iii) Permission to use copyright questionnaire/Pro forma: Not applicable
(j) Maintain the confidentiality of subject Confidentiality of the participants will be
maintained. Whether available resources are adequate: Yes
1. Other resources needed: No
2. For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal
required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw
Description:
Pattern of clinical presentation of different breast disease in surgical opd at BPKIHS
INTRODUCTION
Breast is a dynamic gland that experiences physiological changes throughout a female's
reproductive years. Adolescence, menarche, and menopause are notable periods during which
significant changes occur in the breasts. Breast diseases are more prevalent in females and
encompass a spectrum of benign, infectious, and malignant disorders. Benign breast diseases,
constituting the majority of cases, encompass a range of lesions, including developmental
abnormalities, inflammatory lesions, epithelial, and stromal proliferations, as well as
various neoplasms.
Benign breast disease is the primary cause of breast problems, with up to 30% of women
experiencing a benign breast disorder that requires treatment at some point in their lives.
The most common symptoms associated with these disorders are pain, lumpiness, or the presence
of a lump.
Breast cancer is most commonly observed in the Western world and is extremely rare before the
age of 20 years. It is also rare in males. Breast cancer occurs more frequently in women with
a family history of the disease. The typical presentation of breast cancer involves the
presence of a hard lump, which may be associated with indrawing of the nipple or overlying
skin.
A study conducted in Nepal revealed that benign breast conditions accounted for 61.7% of
cases, while malignancy accounted for 15.3%.
Pain is one of the most common breast symptoms experienced by women. Breast pain is typically
classified as cyclical mastalgia, noncyclical mastalgia, or extra mammary (non-breast) pain.
Cyclic mastalgia is breast pain that follows a clear relationship to the menstrual cycle.
Noncyclic mastalgia may be constant or intermittent and is not linked to the menstrual cycle;
it often occurs after menopause. Extramammary pain arises from the chest wall or other
sources but is interpreted as originating within the breast. The risk of cancer in a woman
presenting with breast pain as her only symptom is extremely low.
Breast lump/mass is also one of the most common breast symptoms. The discovery of a breast
mass, whether self-detected or identified by a clinician, is a common and often distressing
occurrence for many women. Although most detected breast masses are benign, it is essential
for every woman presenting with a breast mass to undergo evaluation to rule out or diagnose
cancer.
Nipple discharge ranks as the third most common breast complaint, following breast pain and
breast mass. It is usually a benign condition and can present in several forms, including
milky, multicolored and sticky, purulent, clear and watery, yellow or serous, pink or
serosanguinous, and bloody or sanguinous. The characteristics of the nipple discharge aid in
the early diagnosis and management of breast disease. The most common cause of pathologic
nipple discharge is a benign papilloma, followed by ductal ectasia, while carcinoma is the
least likely cause.
Breast diseases represent a significant health concern worldwide, including Nepal. Despite
this, there have been relatively few studies conducted in Nepal to investigate the spectrum
of breast diseases, and the available studies have been limited by small sample sizes. The
current study aims to address this knowledge gap by examining the demographic profile of
breast-related diseases and the rate of malignancy in our specific setting. The findings of
this study can provide valuable information for healthcare providers in Nepal to improve
early detection and management of breast diseases. Furthermore, it can serve as a foundation
for future research to better understand the burden and nature of breast diseases in our
population. This study's contribution to the global knowledge of breast diseases is
particularly valuable, especially in countries with limited resources and healthcare
infrastructure. Ultimately, the study seeks to enhance health outcomes and improve the
quality of life for individuals affected by breast diseases in Nepal.
In a study conducted in Olabisi Onabanjo University Teaching Hospital in Nigeria, breast lump
was the commonest clinical feature of breast disease. Over 60% of these were benign. Breast
pain was a statistically significant presentation in patients with malignant breast disease.
In a study carried out at Chaudhry Rehmat Ali Memorial Trust Teaching Hospital Township
Lahore, the commonest presentation was lump breast alone and it accounted for 50 patients of
142(35%). The other common symptom was lumpiness (19%) and pain in breast (14%).
In a prospective study conducted in HBS Hospital Islamabad, which included total of 225
female patients, frequency of the disorders was as follows. Fibroadenoma breast presenting as
lump breast was found in n=69(30.6%) followed by cyclical mastalgia(n=62 (27.5%), breast
abscess n=27(12%), duct ectasia n=18(8%), carcinoma breast n=13(5.7%), sebaceous cyst breast
n=9(4%), mastitis n=8(3%), cracked nipples n=8(3%), noncyclical mastalgia n=4(1.7%),
galactorrhea n=3(0.8%), breast budding n=1(0.4%), phyllodes tumor n=1(0.4%), blood stained
nipple discharge n=1(0.4%) and nipple eczema n=1(0.4%).
In a three years study done in Maheshwara Medical College and Hospital in India 117 patients
(110 Female and 7 Male) were studied. The maximum number of patients presented clinically
with a lump in the breast (31.81%) and the second symptom was a pain in the breast (27.37%).
The common breast diseases were benign and malignant neoplasms. In the benign conditions,
most common was fibroadenoma (69 patients 62.72%) in young females. In older age >40 years,
the breast cancer was common. All the seven male patients with breast enlargement clinically,
diagnosed as gynecomastia and histopathologically confirmed.
A prospective descriptive study conducted between January 2015 and May 2015 at Manipal
Teaching Hospital, a tertiary level hospital situated in western region of Nepal where 160
patients presenting with benign breast diseases were studied. Majority were female (96%). The
commonest presentation of benign breast diseases was pain (45%), followed by lump (26%).
Fibroadenoma accounted for 46%. This study showed that among the benign breast diseases in
females there were preponderance of mastalgia and fibroadenoma followed by fibrocystic
diseases.
METHODS
The research utilized a Descriptive Research Design to investigate various study variables.
The study focused on socio-demographic characteristics such as age, sex, and address, as well
as breast symptoms like pain, lump, discharge, nipple retraction, and sub-areolar fistula.
These factors served as outcome variables in the study. The research was conducted at B.P.
Koirala Institute of Health Sciences (BPKIHS), and the study population consisted of patients
who presented with breast and related complaints in the Surgical OPD. The sampling method
included all patients who attended the surgical OPD with breast-related complaints, and data
was collected using a semi-structured questionnaire through interviews. The sample size was
justified based on literature review and prevalence study calculations. Inclusion criteria
were patients who presented in the Surgical OPD with relevant complaints, while those who
denied consent were excluded. The data collection involved a validated proforma with sections
on sociodemographic profiles and contextual information related to presenting symptoms and
family history. Consent was obtained, and English or Nepali questionnaires were used based on
participant preference.
Data entry was done in Microsoft Excel and the investigators used SPSS v11.5 for statistical
analysis. We used descriptive and inferential statistical methods for data analysis.
Descriptive statistics were presented in percentage, ratio, mean, SD and median along with
presentation in graphical form. Categorical variables were analyzed with the χ2 test or with
Fisher's exact test if at least one cell had an expected count < 5. P value <0.05 was
considered to be significant.
