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Pattern of Clinical Presentation of Different Breast Disease in Surgical Opd at BPKIHS

NCT06026176 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1023

Last updated 2023-09-06

No results posted yet for this study

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

Conditions

  • Breast Disease
  • Breast Neoplasms
  • Breast Pain
  • Breast Fibroadenoma

Sponsors & Collaborators

  • B.P. Koirala Institute of Health Sciences

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026176 on ClinicalTrials.gov