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Study Protocol
Revised

A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol

[version 2; peer review: 1 approved with reservations, 1 not approved]
PUBLISHED 19 Jul 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Fibroadenoma of the breast most often arises during the late teens and early reproductive years. It is the most prevalent tumor in women < 30 years. After the age of 40 to 45, fibroadenomas are rarely observed as new masses in women. Fibroadenomas are made up of both epithelial and stromal components. Fibroadenoma is the most frequent type of breast tumor. It is crucial to diagnose preoperatively, both clinically and pathologically, by using F.N.A.C. Postoperatively, Fibroadenoma is confirmed histopathology. However, malignant transformation is very rare in Fibroadenoma of the breast. Early identification, accurate analysis, and appropriate management are advantageous. The current study's goal is to examine preoperative and postoperative clinicopathological aspects of Fibroadenoma and to assess any differences between preoperative and postoperative diagnosis in patients admitted to Jawaharlal Nehru Medical College, Sawangi (M), Wardha, Maharashtra, India.

Keywords

Fibroadenoma, Breast, F.N.A.C., Histopathological Examination, Benign

Revised Amendments from Version 1

  1. We have made changes in the Objectives.  In objective number 6,  the word incidence has been changed to prevalence as advised by reviewers.
  2. We have stated that only IPD patients are included in the study
  3. We have made changes to the Exclusion criteria as advised by reviewers
  • Lactating women
  • Patients with clinical diagnosis of breast lump other than fibroadenoma

    4. Tenses have been changed as advised by reviewers.

See the authors' detailed response to the review by Omar Hamdy
See the authors' detailed response to the review by Nilotpal Chowdhury

Introduction

Fibroadenoma is a common cause of benign breast lumps in young women between the ages of 15 and 35.1 In Fibroadenoma of the breast, clinical evaluation and fine needle aspiration biopsy is the primary component in formulating a diagnosis and predicting benign or malignant breast lump. Cancer in newly found Fibroadenoma is incredibly uncommon.2 Fibroadenomas frequently appear as firm, easily movable masses that wax and wane with the menstrual cycle and may become larger over several months. Fibroadenoma causes no pain, when touched, moves easily within the breast tissue. All patients with breast lumps in the premenopausal period should be suspected of breast fibroadenoma. Fibroadenomas typically have a size of 2 to 3 cm, but they can grow to > 10 cm and result in asymmetry or hypertrophy of the breasts. The eventual treatment plan depends upon the diagnosis of a breast lump. The applicable methods for diagnosing breast lumps are core needle biopsy (C.N.B.) and fine-needle aspiration cytology (F.N.A.C.). Recent years have seen the development of F.N.A.C. and C.N.B. as highly effective diagnostic techniques for examining palpable breast masses.3 Either a core biopsy or a tiny needle aspiration is used for tissue sampling. The simplicity of the procedure, low cost, and, most importantly, low risk of complications are some of the benefits of F.N.A.C. It is minimally invasive, doesn't call for anesthesia, and is generally patient-friendly.4,5 Additionally, two to four days following aspiration, the results are accessible. The gold standard diagnostic test for Fibroadenoma of the breast is considered to be a surgical biopsy pathological examination. Since it is normal for fibroadenomas to diminish naturally, the majority are just watched. Surgery is advised when the Fibroadenoma becomes larger or the symptoms worsen. Recent research has shown that the prevalence of breast disease is rising. After the age of 40, it is seldom ever observed in women. Fibroadenomas are well-encapsulated lumps that can easily separate from the breast tissue around them. Additionally, many women can avoid excision because a sizeable number of fibroadenomas over a 5-year period remain static or shrink in size.6 Sixty-five percent of patients with fibroadenomas that contain cancer have lobular in situ malignant neoplasms.7

Protocol

Aim

The aim of this study is to compare Preoperative and Postoperative Clinicopathological Correlation of Fibroadenoma of the Breast.

Objectives

  • 1) To study in detail clinical and cytological findings and assessment of Fibroadenoma of breast.

  • 2) To evaluate post operative Histopathological study of fibroadenoma.

  • 3) To compare preoperative clinical findings and Fine Needle Aspiration Cytology study with postoperative Histopathological study.

  • 4) To Know Sensitivity and Specificity of Fine needle aspiration cytology.

  • 5) To know the prevelance of fibroadenoma in different quadrants of breast.

  • 6) To study the prevelance of different benign breast diseases.

Methods

Ethical considerations

Ethical approval received by Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha (Approval number DMIHER (DU)/IEC/2023/953).

Study design and setting

The study will be carried out at the Acharya Vinoba Bhave Rural Hospital, a tertiary care facility affiliated with the Jawaharlal Nehru Medical College in Sawangi, Meghe, Wardha, Maharashtra.

In this prospective comparative study, a total of 75 Patients attending the admitted to the Inpatient department (I.P.D.) of the Surgery department at A.V.B.R.H., Sawangi, Wardha, fulfilling the inclusion criteria will be chosen.

Inclusion criteria

  • All patients admitted to Our Hospital with a provisional clinical diagnosis of Fibroadenoma and willing to give consent for the study.

  • Premenopausal women.

Exclusion criteria

  • Postmenopausal women

  • Women on hormonal therapy

  • Lactating women

  • Patients with clinical diagnosis of breast lump other than fibroadenoma

Methods

After receiving the written informed consent from study participants to participate in the study and for publication of their data, patients who presented with a history of a breast lump were clinically, and F.N.A.C. was confirmed to have Fibroadenoma of the breast. Patients will be asked about their age, residence, social status, clinical history, past history, personal history, family history and will undergo physical examination of breast, local examination of breast, inspection and palpation of breast, examination of lymph nodes, blood investigations, F.N.A.C. preoperatively and histopathology postoperatively in that order. Frequency and percentage will be used to express categorical data. The Chi-square test will be used to analyze the relationship between variables. Mean and Standard Deviation will be used to express quantitative data. For diagnosis, histopathological findings is linked with F.N.A.C. Calculations will be made for the test's sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Statistics will be considered significant for P values under 0.05.

Statistical analysis

Sample size

Daniel formula for sample size:

n=Zα/22xP1P÷E2

Where

Z α/22 is the level of significance at 5 %, i.e., 95 % confidence interval = 1.96

P = Prevalence of fibroadenoma of breast =10./. = 0.10

E = Desired Error of margin = 7% = 0.07

n=1.962x0.10x10.10÷0.072=70.56

n = 75 patients needed in the study.

Study reference:

Formula reference: Daniel et al. (1977)

Dissemination

The results of article will be published in an indexed journal.

Study status

The proposed study is not yet started. The study is expected to begin in July 2023.

Discussion

It is a prospective comparative study comparing the clinicopathological connection of breast fibroadenoma before and after surgery. Histopathological findings were correlated with F.N.A.C. for the diagnosis of the disease is essential to know how efficient F.N.A.C. is in diagnosing Fibroadenoma of the breast preoperatively.

Early detection and treatment are crucial to lowering mortality rates in breast cancer cases, and cancer in newly detected Fibroadenoma is exceedingly rare.8 The main usage of imaging techniques is for screening. In the majority of patients, treatment depends upon F.N.A.C. (fine needle aspiration cytology) and C.N.B. (core needle biopsy) reports, which claim to be extremely accurate and closely resemble histological results.3

F.N.A.C. is less invasive than core needle biopsies and is more accurate, affordable, and simple to do.9 The common cause of a false negative cytological diagnosis is known to be the absence of a lesion on sampling during aspiration.10 False-negative and ambiguous diagnoses are notably common in F.N.A.C. of invasive lobular cancer. This is due to the fact that a paucicellular smear with mild atypia and infrequent single intact epithelial cells is more likely to result from classic invasive lobular cancer.11

Feichter et al. found that out of 1472 FNAC of the breast. Cytological diagnosis was benign in 1003 cases(68.1%), 239(16.2%) aspirates were inadequate, false negative cases were (9%), and false positive cases were (0.5%).12

Kuijper et al. Conducted a study of histopathological features of Fibroadenoma of the breast in 396 cases. In 32.3% of cases, hyperplasia was discovered. Carcinoma in situ was found in 8 cases (2.0%). In 40.4% of cases, complex histologic characteristics were present, primarily in somewhat older patients. In 8.8% of cases, the surrounding tissue had hyperplasia, which was typically present in older patients.12

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Version 2
VERSION 2 PUBLISHED 27 Sep 2023
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CITE
how to cite this article
Ramala SR, Chandak SR and Chandak M. A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol [version 2; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 12:1227 (https://doi.org/10.12688/f1000research.139323.2)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 2
VERSION 2
PUBLISHED 19 Jul 2024
Revised
Views
2
Cite
Reviewer Report 12 Aug 2024
Nilotpal Chowdhury, All India Institute of Medical Sciences, Rishikesh, India 
Approved with Reservations
VIEWS 2
1. Fine Needle Aspiration is not more accurate than Core Needle Biopsy. This is no longer a matter of opinion. Even Systematic Reviews have been published for the same e.g. Wang M, et al., 2017 [Ref-2]. Please change reference that it is ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chowdhury N. Reviewer Report For: A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol [version 2; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 12:1227 (https://doi.org/10.5256/f1000research.168504.r305163)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
5
Cite
Reviewer Report 27 Jul 2024
Omar Hamdy, Mansoura University, Mansoura, Dakahlia Governorate, Egypt 
Not Approved
VIEWS 5
The article still adds a non-necessary unjustified step in the management of ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Hamdy O. Reviewer Report For: A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol [version 2; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 12:1227 (https://doi.org/10.5256/f1000research.168504.r305162)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 1
VERSION 1
PUBLISHED 27 Sep 2023
Views
14
Cite
Reviewer Report 02 May 2024
Omar Hamdy, Mansoura University, Mansoura, Dakahlia Governorate, Egypt 
Not Approved
VIEWS 14
Thanks for your work. The following remarks are to be noted:

1. Abstract:
  • FNAC is not crucial in fibroadenoma in modern surgical practice.
  • Early identification does not make a significant difference in
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Hamdy O. Reviewer Report For: A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol [version 2; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 12:1227 (https://doi.org/10.5256/f1000research.152591.r261982)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 19 Jul 2024
    Sandeep Reddy Ramala, General surgery, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, wardha, 442107, India
    19 Jul 2024
    Author Response
    1. Abstract
    -  In most of Indian hospitals. it was standard technique that FNAC is done in most of the breast lump patients. because as number of cases of breast ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 19 Jul 2024
    Sandeep Reddy Ramala, General surgery, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, wardha, 442107, India
    19 Jul 2024
    Author Response
    1. Abstract
    -  In most of Indian hospitals. it was standard technique that FNAC is done in most of the breast lump patients. because as number of cases of breast ... Continue reading
Views
12
Cite
Reviewer Report 17 Apr 2024
Nilotpal Chowdhury, All India Institute of Medical Sciences, Rishikesh, India 
Approved with Reservations
VIEWS 12
1. With the presently calculated sample size, the researchers will get only 0.1*75 =7-8 cases of fibroadenoma for their study. Just these many cases of fibroadenoma is not sufficient to fully describe the clinicopathological characteristics of breast fibroadenomas. The sample ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Chowdhury N. Reviewer Report For: A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast: A study protocol [version 2; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2024, 12:1227 (https://doi.org/10.5256/f1000research.152591.r261966)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 19 Jul 2024
    Sandeep Reddy Ramala, General surgery, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, wardha, 442107, India
    19 Jul 2024
    Author Response
    1. Sample size - I had calculated sample size as per literature in standardized manner. sample size is calculated by using Daniel formula. In my study I had included total ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 19 Jul 2024
    Sandeep Reddy Ramala, General surgery, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, wardha, 442107, India
    19 Jul 2024
    Author Response
    1. Sample size - I had calculated sample size as per literature in standardized manner. sample size is calculated by using Daniel formula. In my study I had included total ... Continue reading

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 27 Sep 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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