xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026176</url>
    </required_header>
    <id_info>
      <org_study_id>IRC/2433/022</org_study_id>
      <nct_id>NCT06026176</nct_id>
    </id_info>
    <brief_title>Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS</brief_title>
    <official_title>Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>B.P. Koirala Institute of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>B.P. Koirala Institute of Health Sciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD&#xD;
        AT BPKIHS&#xD;
  &#xD;
        Rationale: The Study will help us to know about pattern of presentation of different breast&#xD;
        diseases&#xD;
  &#xD;
        Aims and Objectives:&#xD;
  &#xD;
          1. To investigate the pattern of symptoms in patients with Breast diseases&#xD;
  &#xD;
          2. To assess the burden of different Breast diseases. Research Hypothesis (if relevant):&#xD;
             N/A&#xD;
  &#xD;
        1. Material &amp; Methods:&#xD;
  &#xD;
          1. Whether study involves Human/animals or both : Human&#xD;
  &#xD;
          2. Population/ participants: Files of patients presenting in Surgical OPD with Breast&#xD;
             related complaints&#xD;
  &#xD;
          3. Type of study design: : Descriptive Research Design&#xD;
  &#xD;
          4. Human study :&#xD;
  &#xD;
             Inclusion Criteria: Patients presenting in Surgical OPD with Breast and related&#xD;
             complaints Exclusion Criteria: Those who deny consent for participation.&#xD;
  &#xD;
          5. Expected sample size : 823 Sample size calculation: Mentioned in methodology&#xD;
  &#xD;
          6. Control groups : N/A&#xD;
  &#xD;
          7. Probable duration of study: 365 days&#xD;
  &#xD;
          8. Setting: Outpatient Department&#xD;
  &#xD;
          9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic&#xD;
             characteristics such as age, gender, address. ii. Family History&#xD;
  &#xD;
        Dependent Variables:&#xD;
  &#xD;
        i. Clinical symptoms associated with breast disease ii. Type of breast disease (benign or&#xD;
        malignant)&#xD;
  &#xD;
        Outcome measures:&#xD;
  &#xD;
        Primary (main outcome): All dependent variables&#xD;
  &#xD;
        (i) Rational for statistical methods to be employed : Retrospective Study Data will be&#xD;
        entered in Microsoft Excel and converted it into SPSS for statistical analysis For&#xD;
        descriptive studies, percentage, ratio, mean, SD, median will be calculated along with&#xD;
        graphical and tabular presentations.&#xD;
  &#xD;
        For inferential statistics, bivariate analysis will be done using χ2 test and independent t&#xD;
        test to find out the significant differences between dependent and independent variables at&#xD;
        95% confidence interval and p-value significant at &lt;0.05. Multivariate logistic regression&#xD;
        will be done to adjust for confounding.&#xD;
  &#xD;
        (ii) Ethical clearance : Ethical clearance will be obtained from Under Graduate Medical&#xD;
        Research Protocol Review Board (UM-RPRB) of BPKIHS.&#xD;
  &#xD;
        (iii) Permission to use copyright questionnaire/Pro forma: Not applicable&#xD;
  &#xD;
        (j) Maintain the confidentiality of subject Confidentiality of the participants will be&#xD;
        maintained. Whether available resources are adequate: Yes&#xD;
  &#xD;
          1. Other resources needed: No&#xD;
  &#xD;
          2. For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal&#xD;
             required/ Not required/Received/ Applied when_____ B. Safety measure C. Plan to withdraw&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pattern of clinical presentation of different breast disease in surgical opd at BPKIHS&#xD;
  &#xD;
        INTRODUCTION&#xD;
  &#xD;
        Breast is a dynamic gland that experiences physiological changes throughout a female's&#xD;
        reproductive years. Adolescence, menarche, and menopause are notable periods during which&#xD;
        significant changes occur in the breasts. Breast diseases are more prevalent in females and&#xD;
        encompass a spectrum of benign, infectious, and malignant disorders. Benign breast diseases,&#xD;
        constituting the majority of cases, encompass a range of lesions, including developmental&#xD;
        abnormalities, inflammatory lesions, epithelial, and stromal proliferations, as well as&#xD;
        various neoplasms.&#xD;
  &#xD;
        Benign breast disease is the primary cause of breast problems, with up to 30% of women&#xD;
        experiencing a benign breast disorder that requires treatment at some point in their lives.&#xD;
        The most common symptoms associated with these disorders are pain, lumpiness, or the presence&#xD;
        of a lump.&#xD;
  &#xD;
        Breast cancer is most commonly observed in the Western world and is extremely rare before the&#xD;
        age of 20 years. It is also rare in males. Breast cancer occurs more frequently in women with&#xD;
        a family history of the disease. The typical presentation of breast cancer involves the&#xD;
        presence of a hard lump, which may be associated with indrawing of the nipple or overlying&#xD;
        skin.&#xD;
  &#xD;
        A study conducted in Nepal revealed that benign breast conditions accounted for 61.7% of&#xD;
        cases, while malignancy accounted for 15.3%.&#xD;
  &#xD;
        Pain is one of the most common breast symptoms experienced by women. Breast pain is typically&#xD;
        classified as cyclical mastalgia, noncyclical mastalgia, or extra mammary (non-breast) pain.&#xD;
        Cyclic mastalgia is breast pain that follows a clear relationship to the menstrual cycle.&#xD;
        Noncyclic mastalgia may be constant or intermittent and is not linked to the menstrual cycle;&#xD;
        it often occurs after menopause. Extramammary pain arises from the chest wall or other&#xD;
        sources but is interpreted as originating within the breast. The risk of cancer in a woman&#xD;
        presenting with breast pain as her only symptom is extremely low.&#xD;
  &#xD;
        Breast lump/mass is also one of the most common breast symptoms. The discovery of a breast&#xD;
        mass, whether self-detected or identified by a clinician, is a common and often distressing&#xD;
        occurrence for many women. Although most detected breast masses are benign, it is essential&#xD;
        for every woman presenting with a breast mass to undergo evaluation to rule out or diagnose&#xD;
        cancer.&#xD;
  &#xD;
        Nipple discharge ranks as the third most common breast complaint, following breast pain and&#xD;
        breast mass. It is usually a benign condition and can present in several forms, including&#xD;
        milky, multicolored and sticky, purulent, clear and watery, yellow or serous, pink or&#xD;
        serosanguinous, and bloody or sanguinous. The characteristics of the nipple discharge aid in&#xD;
        the early diagnosis and management of breast disease. The most common cause of pathologic&#xD;
        nipple discharge is a benign papilloma, followed by ductal ectasia, while carcinoma is the&#xD;
        least likely cause.&#xD;
  &#xD;
        Breast diseases represent a significant health concern worldwide, including Nepal. Despite&#xD;
        this, there have been relatively few studies conducted in Nepal to investigate the spectrum&#xD;
        of breast diseases, and the available studies have been limited by small sample sizes. The&#xD;
        current study aims to address this knowledge gap by examining the demographic profile of&#xD;
        breast-related diseases and the rate of malignancy in our specific setting. The findings of&#xD;
        this study can provide valuable information for healthcare providers in Nepal to improve&#xD;
        early detection and management of breast diseases. Furthermore, it can serve as a foundation&#xD;
        for future research to better understand the burden and nature of breast diseases in our&#xD;
        population. This study's contribution to the global knowledge of breast diseases is&#xD;
        particularly valuable, especially in countries with limited resources and healthcare&#xD;
        infrastructure. Ultimately, the study seeks to enhance health outcomes and improve the&#xD;
        quality of life for individuals affected by breast diseases in Nepal.&#xD;
  &#xD;
        In a study conducted in Olabisi Onabanjo University Teaching Hospital in Nigeria, breast lump&#xD;
        was the commonest clinical feature of breast disease. Over 60% of these were benign. Breast&#xD;
        pain was a statistically significant presentation in patients with malignant breast disease.&#xD;
  &#xD;
        In a study carried out at Chaudhry Rehmat Ali Memorial Trust Teaching Hospital Township&#xD;
        Lahore, the commonest presentation was lump breast alone and it accounted for 50 patients of&#xD;
        142(35%). The other common symptom was lumpiness (19%) and pain in breast (14%).&#xD;
  &#xD;
        In a prospective study conducted in HBS Hospital Islamabad, which included total of 225&#xD;
        female patients, frequency of the disorders was as follows. Fibroadenoma breast presenting as&#xD;
        lump breast was found in n=69(30.6%) followed by cyclical mastalgia(n=62 (27.5%), breast&#xD;
        abscess n=27(12%), duct ectasia n=18(8%), carcinoma breast n=13(5.7%), sebaceous cyst breast&#xD;
        n=9(4%), mastitis n=8(3%), cracked nipples n=8(3%), noncyclical mastalgia n=4(1.7%),&#xD;
        galactorrhea n=3(0.8%), breast budding n=1(0.4%), phyllodes tumor n=1(0.4%), blood stained&#xD;
        nipple discharge n=1(0.4%) and nipple eczema n=1(0.4%).&#xD;
  &#xD;
        In a three years study done in Maheshwara Medical College and Hospital in India 117 patients&#xD;
        (110 Female and 7 Male) were studied. The maximum number of patients presented clinically&#xD;
        with a lump in the breast (31.81%) and the second symptom was a pain in the breast (27.37%).&#xD;
        The common breast diseases were benign and malignant neoplasms. In the benign conditions,&#xD;
        most common was fibroadenoma (69 patients 62.72%) in young females. In older age &gt;40 years,&#xD;
        the breast cancer was common. All the seven male patients with breast enlargement clinically,&#xD;
        diagnosed as gynecomastia and histopathologically confirmed.&#xD;
  &#xD;
        A prospective descriptive study conducted between January 2015 and May 2015 at Manipal&#xD;
        Teaching Hospital, a tertiary level hospital situated in western region of Nepal where 160&#xD;
        patients presenting with benign breast diseases were studied. Majority were female (96%). The&#xD;
        commonest presentation of benign breast diseases was pain (45%), followed by lump (26%).&#xD;
        Fibroadenoma accounted for 46%. This study showed that among the benign breast diseases in&#xD;
        females there were preponderance of mastalgia and fibroadenoma followed by fibrocystic&#xD;
        diseases.&#xD;
  &#xD;
        METHODS&#xD;
  &#xD;
        The research utilized a Descriptive Research Design to investigate various study variables.&#xD;
        The study focused on socio-demographic characteristics such as age, sex, and address, as well&#xD;
        as breast symptoms like pain, lump, discharge, nipple retraction, and sub-areolar fistula.&#xD;
        These factors served as outcome variables in the study. The research was conducted at B.P.&#xD;
        Koirala Institute of Health Sciences (BPKIHS), and the study population consisted of patients&#xD;
        who presented with breast and related complaints in the Surgical OPD. The sampling method&#xD;
        included all patients who attended the surgical OPD with breast-related complaints, and data&#xD;
        was collected using a semi-structured questionnaire through interviews. The sample size was&#xD;
        justified based on literature review and prevalence study calculations. Inclusion criteria&#xD;
        were patients who presented in the Surgical OPD with relevant complaints, while those who&#xD;
        denied consent were excluded. The data collection involved a validated proforma with sections&#xD;
        on sociodemographic profiles and contextual information related to presenting symptoms and&#xD;
        family history. Consent was obtained, and English or Nepali questionnaires were used based on&#xD;
        participant preference.&#xD;
  &#xD;
        Data entry was done in Microsoft Excel and the investigators used SPSS v11.5 for statistical&#xD;
        analysis. We used descriptive and inferential statistical methods for data analysis.&#xD;
        Descriptive statistics were presented in percentage, ratio, mean, SD and median along with&#xD;
        presentation in graphical form. Categorical variables were analyzed with the χ2 test or with&#xD;
        Fisher's exact test if at least one cell had an expected count &lt; 5. P value &lt;0.05 was&#xD;
        considered to be significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical symptoms associated with breast disease</measure>
      <time_frame>One year</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Type of breast disease (benign or malignant)</measure>
      <time_frame>One Year</time_frame>
    </primary_outcome>
    <enrollment type="Actual">1023</enrollment>
    <condition>Breast Disease</condition>
    <condition>Breast Neoplasms</condition>
    <condition>Breast Pain</condition>
    <condition>Breast Fibroadenoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who presented to the surgical outpatient department (OPD) of a community-based&#xD;
          tertiary care hospital in Nepal. These patients sought medical attention for various&#xD;
          breast-related complaints over a one-year period. The population includes both male and&#xD;
          female individuals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients presenting in Surgical OPD with Breast and related complaints&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who deny consent for participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>BPKIHS</name>
        <address>
          <city>Dharan</city>
          <state>Province 1</state>
          <country>Nepal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Nepal</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>B.P. Koirala Institute of Health Sciences</investigator_affiliation>
      <investigator_full_name>Sishir Poudel</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Fibroadenoma</mesh_term>
      <mesh_term>Breast Diseases</mesh_term>
      <mesh_term>Mastodynia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026176
  org study id: IRC/2433/022
  nct id: NCT06026176
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Clinical symptoms associated with breast disease
  time frame: One year
  measure: Type of breast disease (benign or malignant)
  time frame: One Year
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Nepal
  responsible party type: Principal Investigator
  investigator affiliation: B.P. Koirala Institute of Health Sciences
  investigator full name: Sishir Poudel
  investigator title: Doctor
  mesh term: Breast Neoplasms
  mesh term: Fibroadenoma
  mesh term: Breast Diseases
  mesh term: Mastodynia
  sharing ipd: Undecided