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Research Protocol
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TABLE OF CONTENTS
Title page 1
Table of contents 2
Abstract 3
Introduction 3
Research objectives 5
Conceptual framework 6
Study design 7
Statistical analysis 9
Dummy tables 9
Ethical considerations 9
Gantt chart 11
References 12
Appendices 14
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Abstract
Methods: This cross-sectional study will include females with acute abdominal pain who
underwent appendectomy with subsequent gynecologic pathology findings intraoperatively and
females who underwent emergency gynecologic surgery with subsequent referral for
appendectomy. Prevalence rate, frequency distribution and chi square test to determine
association will be determined in the study.
Introduction
Acute appendicitis is the most common cause of abdominal pain requiring surgery. [1] It is
defined as the inflammation of the vermiform appendix and caries a lifetime risk of 7% accounting
for 27.5% of surgical emergencies. True appendicitis is defined as inflammation of the appendix
which stems out from obstruction of the appendiceal lumen and is characterized by mucosal
ulceration and transmural polymorph infiltrate often with mural necrosis and a serosal
inflammatory response. [2]. While the diagnosis of acute appendicitis appears straightforward,
with established signs and symptoms recognized for years, several medical and surgical
illnesses mimic the disease. [3] in some instances, reactive appendicitis also occurs. Reactive
appendicitis indicates an extra-appendiceal source of inflammation which involves only the
serosa and sub serosal layers of the appendix. [4]
Reactive appendicitis can mimic primary appendicitis, and is difficult to discern clinically
and radiologically, complicating acute appendicitis diagnosis. [5]. The clinical signs and
symptoms of acute appendicitis overlap significantly with those of gynecologic disorders adding
more difficulty in the diagnosis of abdominal pain among women. Furthermore, it has been
shown that there is coexistence of acute appendicitis with a variety of gynecologic diseases; and
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seemingly, gynecological causes are the most important causes of reactive appendicitis. [4,6]
Hence, in women presenting with right lower quadrant pain, acute gynecological disease
processes should be considered aside from a possible acute appendicitis. Ovarian torsion,
hemorrhagic ovarian cyst, pelvic inflammatory disease, and ectopic pregnancy should be
considered within the differential diagnoses while also keeping in mind that reactive appendicitis
may co-occur with these conditions. [7,8]
True appendicitis concomitant with gynecologic pathologies have been shown to occur
however are rarely presented in the literature. Conversely, reactive appendicitis is well known to
be secondary to concomitant gynecologic pathologies, and its incidence has remained to be high.
Reactive appendicitis can mimic true appendicitis clinically and radiologically however treatment
for these entities greatly differ. Presently, very little is known with regards to techniques and pre-
operative diagnostics that differentiate true appendicitis from reactive appendicitis and mainly,
the diagnosis is based on histopathologic reports after appendectomy. The broadly accepted
treatment of choice for true appendicitis is appendectomy however for reactive appendicitis, the
preferred treatment is conservative management, and an appendectomy is not necessary.[9]
Perhaps differentiating true appendicitis from reactive appendicitis pre-operatively, and
determining the prevalence of true appendicitis versus reactive appendicitis occurring
concomitantly with specific gynecological diseases would spare women from unnecessary
operations or invasive procedures. This study then aims to raise the awareness of these
situations to both surgeons and gynecologists and to establish the incidence rate of true
appendicitis vs reactive appendicitis in patients with gynecologic pathology so that further
diagnostic algorithms to improve diagnostic accuracy in women be developed to ensure patient
safety outcomes in this population.
The overall lifetime risk of acute appendicitis is 7% with women having an overall lifetime
risk of 23.1%. [1,4].
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Another study by Alhamdani et al found similar results wherein 64.3% of females had
reactive appendicitis. The most common symptom was abdominal pain in 95% of these cases,
followed by migration of pain (28.6%) and vomiting in 28.6% of cases. They also found out that
there was a significant association between reactive appendicitis and gynecological complaints.
[12]
However, in a study done in Turkey, only 5.8% of women with gynecologic pathologies
had reactive appendicitis, hence underwent subsequent appendectomy. The most common
gynecologic pathology was a ruptured right ovarian cyst in 72.3% of cases. Followed by right
tubo-ovarian abscesses in 3.3%, ectopic pregnancies in 3.3%, right salpingo-oophoritis in 3.3%,
right ovarian torsion in 1.75%, and pelvic inflammatory disease (PID) in 1.75%. [13]
In Asia, in a study of 106 women who underwent laparoscopic surgery to treat ovarian
endometriosis, 34.9% of cases had abnormal findings in their resected appendices, and 4.7% of
which were histologically confirmed to have peri-appendicitis. [14]
Objectives
General objectives
Specific Objectives
▪ Ovarian torsion
▪ Endometriosis
▪ Ectopic pregnancy
▪ Tubo-ovarian abscess
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● To determine the association of gynecologic pathologies and occurrence of true
appendicitis vs reactive appendicitis in female patients
The significance of the study is in line with improving patient safety outcomes by
increasing awareness of the coexistence of true appendicitis and reactive appendicitis, and
gynecologic pathology. Since most of the clinical symptoms of these conditions overlap
significantly, this study encourages surgeons and gynecologists to consider improving diagnostic
algorithms to improve the diagnostic accuracy of both gynecological and non-gynecological
cases of acute abdominal pain.
This study aims to establish the prevalence rate of true appendicitis vs reactive
appendicitis in patients with gynecologic pathology at a tertiary hospital in Baguio City. The study
will be a 1-year study which will include female patients who underwent appendectomy with
intraoperative findings of a gynecologic pathology. The study will be done using a cross-sectional
study design and will involve the participation of the gynecology, surgery, and pathology
departments.
This study, however, will not assess for predictive factors contributing to the coexistence of
true appendicitis and reactive appendicitis with gynecologic pathology.
Conceptual framework
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Reactive appendicitis- inflammation of the appendix that is not due to luminal obstruction,
but due to presence of inflammation of the surrounding organs of the abdomen. Interchangeable
with secondary appendicitis, serosal appendicitis or peri-appendicitis as a histopathologic
diagnosis
Study Design
This is a cross-sectional study that will be conducted at Baguio General Hospital and
Medical Center, a Tertiary Hospital in Baguio City. The duration of the study will be from January
1, 2022, to December 31, 2022, and will commence after ethics approval from a PHREB-
accredited Institutional Review Board.
The population of the study will be women who were admitted who underwent
appendectomy from January 1, 2022, to December 31, 2022. From there, sample selection will
be done using simple random sampling technique.
The inclusion criteria will be female patients with right lower quadrant abdominal pain who
underwent appendectomy with subsequent intraoperative findings of a gynecologic pathology
and patients who underwent emergent gynecologic surgery who were referred intraoperatively to
the Department of Surgery for subsequent appendectomy during the time of the conduct of the
study.
Exclusion criteria will include female patients with acute abdominal pain who had previous
history of appendectomy, patients who underwent gynecologic surgery but not have had
simultaneous appendectomy, non-emergency appendectomies like interval appendectomy or
incidental appendectomy performed during some other non-gynecologic surgery and normal
appendix on histopathology.
Sample size
The minimum sample size requirement of this study is 273 female patients with
gynecologic pathology who underwent emergency appendectomy. This was computed from the
formula for estimating the population proportion based on the following information: (1)
confidence level is set at 95%; (2) expected incidence of female patients who underwent surgery
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with findings of reactive appendicitis with concomitant gynecologic pathology of 23.1% and (3)
margin of error of 5%. Open epi website was utilized in this sample size calculation.
273
NFPC=
● 273−1
1+
100
● NFPC=73
Sampling design
Simple random sampling technique will be used in this study. The participants will include
female patients with acute abdominal pain who underwent appendectomy at BGHMC at the time
of the study period.
Female patients who were admitted and underwent appendectomy will be selected from
the BGHMC operating room HOMIS record and will be listed with the use of an abstraction form.
Simple random sampling technique will be used then the inclusion and exclusion criteria will be
applied. The researcher will then obtain the histologic diagnosis from the Pathology Department
to complete the patient’s data for research.
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Statistical Analysis
Descriptive statistics will be used to summarize the data: frequency and proportion will be
used to describe the most common gynecologic pathologies. Prevalence rate of reactive
appendicitis and true appendicitis in patients with gynecologic pathologies will be computed using
the following formula: the total number of patients with reactive appendicitis or true appendicitis
and concomitant gynecologic pathologies/total sample size. To assess the association between
the presence of true appendicitis vs reactive appendicitis and gynecologic pathology, chi square
test will be used. The statistical analysis will be performed using R (R Core Team (2020). R: A
language and environment for statistical computing. R Foundation for Statistical Computing,
Vienna, Austria. URL https://www.R-project.org/.).
Table I. most common gynecologic pathology that occur concomitantly with true appendicitis
versus reactive appendicitis
Pelvic inflammatory
disease
Ovarian torsion
Endometriosis
Ectopic pregnancy
Tubo-ovarian
abscess
Ethical Considerations
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The protocol of this study adheres to the ethical considerations and ethical principles set
out in relevant guidelines, including the Declaration of Helsinki, WHO guidelines, International
Conference on Harmonization-Good Clinical Practice, Data Privacy Act of 2012, and National
Ethics Guidelines for Health Research 2017.
The study did not have any conflicts of interest that may perhaps arise from
considering financial. All the expenses used in the study were handled by the researcher. The
participants were women who were admitted and underwent appendectomy, and their
participation was highly voluntary; they also had the right to withhold their participation or to
terminate their participation without giving any reasons. Confidentiality of participants’ data will be
preserved by an optional choice of placing their name in the demographic form. Randomized
selection of participants will be done. Personal information given by the participants will be
accessed only by the researcher to fulfill the objectives of the research and will not be used
beyond the scope of the research. No other materials will be passed, and no incentive will be
given.
Conflicts of Interest
No potential conflicts of interest have been identified. The principal investigators and co-
investigators report no disclosures.
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Any cost-related matter requiring for the accomplishment of this study will be financed by
the researcher.
TRB Approval
ERC Submission
ERC Approval
Data Collection
Data Analysis
Formulation of
Discussion
Application for
Research
Completion
Evaluation of
Research
Completion
Public
Dissemination
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Approved by:
DEPARTMENT HEAD: Dr. Fidel A. Baldovino Jr
References:
1. Karam AR, Birjawi GA, Sidani CA, Haddad MC. Alternative diagnoses of acute appendicitis on
helical CT with intravenous and rectal contrast. Clin Imaging. 2007;31(2):77-86.
doi:10.1016/j.clinimag.2006.12.023
2. Louis MA, Doubleday AR, Lin E, Baek JY, Andoni A, Wang XH. Abdominal Pain in the Female
Patient: A Case of Concurrent Acute Appendicitis and Ruptured Endometrioma. Case Rep Surg.
2016;2016:2156148. doi: 10.1155/2016/2156148. Epub 2016 Dec 20. PMID: 28097032; PMCID:
PMC5206420.
3. Joshi MK, Joshi R, Alam SE, Agarwal S, Kumar S. Negative Appendectomy: an Audit of
Resident-Performed Surgery. How Can Its Incidence Be Minimized?. Indian J Surg.
2015;77(Suppl 3):913-917. doi:10.1007/s12262-014-1063-0
4. Pranesh N, Sathya V, Mainprize KS. Serosal appendicitis: incidence, causes and clinical
significance. Postgrad Med J. 2006 Dec;82(974):830-2. doi: 10.1136/pgmj.2006.049916. PMID:
17148708; PMCID: PMC2653932.
5. Kwon LM, Lee K, Min SK, Ahn SM, Ha HI, Kim MJ. Ultrasound features of secondary
appendicitis in pediatric patients. Ultrasonography. 2018;37(3):233-243. doi:10.14366/usg.17029
6. Song JY, Yordan E, Rotman C. Incidental appendectomy during endoscopic surgery. JSLS.
2009;13(3):376-383.
7. Martine A. Louis, Amanda R. Doubleday, Elizabeth Lin, Ji Yoon Baek, Alda Andoni, Xiao Hui
Wang,"Abdominal Pain in the Female Patient: A Case of Concurrent Acute Appendicitis and
Ruptured Endometrioma", Case Reports in Surgery, vol. 2016, Article
ID 2156148, 4 pages, 2016.https://doi.org/10.1155/2016/2156148
8. Thompson JP, Selvaraj D, Nicola R . Mimickers of Acute Appendicitis. J Am Osteopath Coll
Radiol. 2014;3(4):10-21.
9. Kwon LM, Lee K, Min SK, Ahn SM, Ha HI, Kim MJ. Ultrasound features of secondary
appendicitis in pediatric patients. Ultrasonography. 2018 Jul;37(3):233-243.
doi:10.14366/usg.17029. Epub 2017 Aug 25. PMID: 29141286; PMCID: PMC6044217.
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10. Omer Engin, Bulent Calik, Sebnem Calik. Parasitic Appendicitis. January 2012.
DOI:10.5772/25483
11. Borgstein PJ, Gordijn RV, Eijsbouts QA, Cuesta MA. Acute appendicitis--a clear-cut case in
men, a guessing game in young women. A prospective study on the role of laparoscopy. Surg
Endosc. 1997;11(9):923-927. doi:10.1007/s004649900488
12. Alhamdani YF, Rizk HA, Algethami MR, et al. Negative Appendectomy Rate and Risk Factors
That Influence Improper Diagnosis at King Abdulaziz University Hospital. Mater Sociomed.
2018;30(3):215-220. doi:10.5455/msm.2018.30.215-220
13. Engin O, Calik B, Yildirim M, Coskun A, Coskun GA. Gynecologic pathologies in our
appendectomy series and literature review. J Korean Surg Soc. 2011;80(4):267-271.
doi:10.4174/jkss.2011.80.4.267
14. Wie HJ, Lee JH, Kyung MS, Jung US, Choi JS. Is incidental appendectomy necessary in
women with ovarian endometrioma?. Aust N Z J Obstet Gynaecol. 2008;48(1):107-111.
doi:10.1111/j.1479-828X.2007.00811.x
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Appendix A. Coding Manual
Reactive
Appendicitis
yes = 0
no = 1
Patient Histologic Diagnosis of the Gynecologic
No. Appendix Diagnosis
001
002
003
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Appendix B. Curriculum Vitae of the Researcher
Personal Summary
● A physician willing to learn and improve thru extensive exposure to patient assessment,
diagnosis, treatment and rehabilitation.
● Independent, hardworking and determined, effective at multitasking and working under
pressure to accomplish overall objectives.
● Competent and determined to uphold the best quality care to be rendered by a physician.
● Easy going by nature, independent and able to get along with other allied professionals and
senior managers.
Educational Background
Elementary Bontoc Central School
SY 1996-2002 Bontoc, Mountain Province
Work Experience
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1. 2019- 2021
Medical Officer, Department of Surgery, Baguio General Hospital and Medical Center
Reference
Will be provided upon request.
Thru:
Banny Bay C. Genuino, MD, FPSCS, FPSGS, FPHAPBS, FACS
Training Officer, Department of Surgery
Baguio General Hospital and Medical Center
Greetings!
The researcher will be conducting a study entitled “Incidence Of True Appendicitis Vs
Reactive Appendicitis In Patients With Gynecologic Pathology In Baguio General Hospital
And Medical Center”. In this regard, I am asking your permission to start the data collection
starting January 1, 2022 to December 31, 2022. The data that will be collected will include the
most common gynecologic pathologies associated with appendicitis at Baguio General Hospital
and Medical Center. Consent in interviewing and patient’s privacy and confidentiality will be
strictly followed.
Sincerely yours,
Ferdinand B. Tuzon Jr., MD
Researcher
Noted by:
Dr. Fidel A. Baldovino Jr
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Dr. Banny Bay C. Genuino
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