Descriptive and Correlational Study of the Epidemiological, Clinical and Etiological Characteristics of Peritonitis in the Surgical Department of the State University Hospital of Haiti During the Period From January 2013 to December 2018
Conditions: Peritonitis
Sponsor: Universite d'Etat d'Haiti

I 
 
 
Descriptive and correlational study of the epidemiological, clinical and 
etiological characteristics of peritonitis in the surgical department of the 
HUEH during the period from January 2013 to December 2018 
 
NCT04182217 
 
October 15, 2019 
 
 
 
 
 
 
 
 
 

II 
 
 
Study Protocol 
 
 
 
 
 

III 
 
 
Table of Contents 
Lists of abbreviations ............................................................................................................................. iv 
Title .......................................................................................................... Error! Bookmark not defined. 
Research Synopsis ................................................................................................................................... v 
Introduction ............................................................................................................................................. 1 
Background ......................................................................................................................................... 1 
Rationale ............................................................................................................................................. 2 
Aim ...................................................................................................................................................... 2 
Objectives of the project..................................................................................................................... 2 
Methodology ........................................................................................................................................... 4 
Study Type and Design ........................................................................................................................ 4 
Study Population ................................................................................................................................. 4 
Inclusion Criteria ............................................................................................................................. 4 
Exclusion Criteria ............................................................................................................................. 4 
Sample Size ......................................................................................................................................... 4 
Study Duration and Timeline .............................................................................................................. 5 
Statistical Analysis Plan ....................................................................................................................... 5 
Risk and benefit to study participants ................................................................................................ 6 
Ethics of Study ..................................................................................................................................... 6 
Informed Consent/Assent Process ...................................................................................................... 7 
Funding ............................................................................................................................................... 7 
Publication Policy ................................................................................................................................ 7 
Reference ................................................................................................................................................ A 
 
 
 
 
 
 
 

IV 
 
Lists of abbreviations 
ANOVA .................................................................................................................... Analysis of variance 
APACHE ..................................................................... Acute physiology and chronic health evaluation 
FMP .................................................................................................. Faculty of Medicine and Pharmacy 
Hb ...................................................................................................................... hemoglobin, Hemoglobin 
HR .......................................................................................................................... Heart rate, Heart rate 
HUEH ..................... Hospital of the State University of Haiti (, Hospital of the State University of Haiti 
LABMES Laboratory of Ethical Medicine and Societies, Laboratory of Ethical Medicine and Societies 
MPI .............................................................................................................. Mannheim peritonitis index 
RR ....................................................................................................... Respiratory rate, Respiratory rate 
SAPS ................................................................................................... Simplified acute physiology score 
SSS ........................................................................................................................... Sepsis severity score 
T Temperature, Temperature 
UEH .................................................................................................................... State University of Haiti 
WBC .......................................................................................... white blood cell count, white blood cell 
 
 
 

V 
 
Research Synopsis 
 
Study title 
Descriptive and correlational study of the epidemiological, 
clinical and etiological characteristics of peritonitis in the 
surgical department of the HUEH during the period from 
January 2013 to December 2018 
Study Population 
All patients diagnosed, hospitalized and operated on in 
the peritonitis ward during January 2013 to December 2018 
Study Design 
correlational descriptive study, retrospectively carried out over a 
period of 6 years, from January 2013 to December 2018 in the 
surgical department of the HUEH 
General Objective 
To study the prevalence, etiology, and factors associated with 
the severity of peritonitis and its complications in the 
department of surgery at HUEH.  
Specific Objectives 
 Identify epidemiological characteristics. 
 Describe the main etiologies encountered in the service  
 Measure the time required for treatment and its consequences 
on the evolution of peritonitis. 
Sample Size 
91 patients 
Study Duration 
January 2013 to December 2018 
 
 
 
 

1 
 
Introduction 
Background 
Generalized secondary peritonitis is one of the most common emergencies encountered 
in surgical departments (1). It is a major surgical condition with a mortality of up to 20% and 
classified as the third most common cause of surgical abdomens after appendicitis and 
intestinal obstruction (2). Despite advances in surgical techniques,  its management remains 
difficult and complex and it has been reported as one of the most lethal non traumatic conditions 
in the department emergency around the world (3,4). Several factors such as: age, sex, failing 
organs, malignancy, peritonitis extension, type of contamination, site of perforation, surgery, 
co-morbidities, severity of sepsis, treatment delay and immunosuppression, are known to 
influence mortality and morbidity (4). There is an etiological disparity between developed and 
developing countries. It was noted that infectious peritonitis dominates the picture in 
developing countries while perforation cases are the majority in developed countries (5,6). 
Infectious peritonitis dominates the picture in developing countries while perforation cases are 
the majority in developed countries, generally the observations show patients in low-income 
countries tend to have perforations of the proximal intestine, while in the western world they 
are more often affected by perforations of the large intestine (4,7). Delays in surgical 
management are known as conditions that increase mortality and generally  the three main 
sources of delay in surgery are: delays in seeking care after the onset of symptoms, delays in 
arriving at the hospital in a timely manner, and delays in surgical management (8). While early 
prognostic assessment of peritonitis is essential for the objective classification of the severity 
of the disease, the late presentation of the majority of patients to health facilities affects this 
situation, further complicating effective management and promoting the occurrence of 
complications (9). Muralidhar observed that mortality was 5% in patients who presented within 
24 hours, 13% in patients who presented between 2 to 5 days and 50% in patients who presented 
after 5 days. (10) Thus, as the delay is significant, the risk of mortality becomes greater. It has 
been observed that classifying the severity of peritonitis has a major contribution to decision-
making and improves management (10). Many scoring systems have been designed and 
successfully used to assess the severity of acute peritonitis, including: Acute physiology and 
chronic health evaluation (APACHE) II score, Simplified acute physiology score (SAPS), 
Sepsis severity score (SSS), Ranson score, Imrite score, Mannheim peritonitis index (MPI). 
The Mannheim Peritonitis Index (MPI) is a specific score, which is highly accurate and allows 
clinical parameters to be easily manipulated, allowing the individual prognosis of patients with 

2 
 
peritonitis to be predicted. It is an independent, objective and effective rating system for 
predicting mortality and has advantages over the other rating systems described above (10,11).  
Rationale 
Knowing these characteristics, namely the importance of delays and the severity score, 
will help to better manage the disease and its progression both in terms of diagnosis and 
therapy. Hence the interest of this study in our environment, where coming to the hospital is 
often the last choice of patients due to lack of resources sometimes, but especially because of 
a lack of information particularly on surgical pathologies. In Haiti, few studies on surgical 
pathologies are available, and with regard to peritonitis, only two thesis works have been listed 
on the subject, including one carried out at the Justinian University Hospital of Cap-Haitien on 
176 patients by Dr. Jacques JULMICE, who presents the main etiologies of peritonitis over a 
5-year perioda. And the other one carried out at the Albert Schweitzer Hospital by Dr. Moise 
ARISTIDE, still on the etiological factors of peritonitisb. These two studies are carried out 
outside the country's metropolitan region (the most populated region) and that they only 
explored the different etiologies without taking into account the time required for treatment 
and the gravity factors of peritonitis.  
Aim 
1) Our study aims to explore the demographic, clinical and etiological characteristics of 
peritonitis in the main referral hospital in the metropolitan region of the Haiti 
2) Evaluate the main delays (onset of symptoms, pre-op, post-op and stay time at hospital) 
and its relationship with the severity of the disease by measuring the MPI score. 
 
Objectives of the project  
Primary objective: 
To study the prevalence, etiology, and factors associated with the severity of peritonitis 
and its complications in the service of HUEH Surgery.  
                                                          
a Dr. Jacques JULMICE. ETUDE SUR LES PARTICULARITES ETIOLOGIQUES DE LA PERITONITE 
SECONDAIRE A L’HOPITAL UNIVERSITAIRE JUSTINIEN ,DR JACQUES JULMICE(ETUDE 
RETROSPECTIVE JANVIER 2003-DECEMBRE 2007) - Unpublished manuscript [Internet]. 2010 
[cited 2019 Apr 15]. Available from: http://atelier.rfi.fr/profiles/blogs/etude-sur-les-particularites 
 
b ARISTIDE M. Facteurs étiologiques des péritonites infectieuses généralisées, Unpublished manuscript. 
Université notre dame d’Haïti, Faculté de médecine et des sciences de la santé. Université notre dame d’Haïti; 
2013. 

3 
 
Secondary objectives:  
¬ Identify epidemiological characteristics. 
¬ Describe the main etiologies encountered in the service 
¬ Measure the time required for treatment and its consequences on the evolution 
of peritonitis. 

4 
 
Methodology 
 
Study Type and Design  
It is a correlational descriptive study, retrospectively carried out over a period of 6 
years, from January 2013 to December 2018 in the surgical department of the HUEH  
The study is being conducted in the Surgery Department of the Hospital of the State 
University of Haiti (HUEH). It is a university hospital, the main training center of the Faculty 
of Medicine and Pharmacy (FMP) of the State University of Haiti (UEH). 
Study Population 
The study population is composed of all patients diagnosed, hospitalized and operated on in the 
peritonitis ward during the study period. 
Inclusion Criteria   
 Patients whose peritonitis diagnosis was made and operated on in the department 
during the period. 
 Patient whose record is identified (with age, sex) with at least the clinical and 
etiological diagnosis identified in the operating protocol. 
Exclusion Criteria 
 Patients with incomplete records. 
 Cases of post-operative peritonitis. 
 Patient under 10 years of age 
Sample Size   
Sampling is probabilistic, simple random sampling. The sample size is randomly 
determined from Epi Info 7. To estimate the sample size, we considered the peritonitis 
prevalence of an African study on the particularity of peritonitis in tropical environments, an 
environment that reflects our reality in ecological, demographic and epidemiological terms, 
namely 19% (5). The standard error rate chosen was 5%. This allows us to estimate our sample 
at 88 with a confidence interval of 97%. Given the possibility of finding missing files at HUEH, 
our sample was adjusted to 20% (standard non-response rate), by the formula: (Adjusted 
sample) = (Initial sample) + (Probable non-response). Thus the Adjusted sample becomes 106. 
The sample was listed on a unit list consisting of all files recorded during the study period. The 
files were numbered from 1, the numbers were chosen at random, from the batches of 10 the 
first 106 were chosen randomly. (annexes) 

5 
 
Study Duration and Timeline  
Protocol writing and reviewed from: August 2018 to December 2018 
Data collection from: March 2019 to May 2019 
Data Analysis from: May 2019 to August 2019 
Correction and reviewing from: September 2019 to November 2019 
Presentation and Publication from: November 2019 to December 2019 
Statistical Analysis Plan 
An individual collection sheet, prepared on the Epi Info 7 software, was used, which 
contains a part for demographic and identity data, a part for vital signs, another part for clinical 
and para-clinical data and a part for intraoperative data. Data collection was conducted in the 
surgical department's archive room, according to the principles mentioned above in the ethical 
consideration. A file is considered complete (and therefore accepted) if it contains: 
demographic data, clinical diagnosis and operating protocol. Identity information is taken from 
the first record recorded for the patient. The information concerning the clinical diagnosis is 
taken from the admission note and the vital signs considered are those found in this first note. 
For the data of the para clinical examinations only the first examinations, i.e. the closest to the 
date of admission, were considered. Intraoperative diagnostic data are collected directly from 
the operating protocol. For complications and management, only information from the progress 
notes closest to the date of the intervention was considered. Quantitative variables are measured 
by calculating the mean, and quartiles, and categorical variables by calculating frequencies and 
percentages. other quantitative variables were transformed into qualitative variables such as: 
heart rate with 3 modalities (bradycardia if  HR < 60 ; normal between 60-100 and tachycardia 
if > 100); respiratory rate (bradypnea if RR < 12 ; normal between 12-20 and tachypnea if > 
20) ; temperature (hypothermia if T < 3 6.5; normal between 36.5 - 75.5 and hyperthermia if 
>37.5); hemoglobin level (normal if Hb > 12 gram; abnormal if < 12 gram); white blood cell 
count (leukopenia if WBC < 5000 ; normal between 5000- 10000 ; leukocytosis if > 10000) ; 
urea (normal between 20-40 mg/dl) creatinine (normal between 0.4-1.40 mg/dl). For the 
qualitative variables, they were presented according to several modalities such as: sex 
according to two modalities (Male, Female); marital status according to three modalities 
(Married, single, not mentioned); academic level according to five modalities (elementary, 
student, university, illiterate, not mentioned); address according to five modalities (Port-au-
Prince commune, Carrefour commune, Delmas commune, Petion-ville commune, outside the 

6 
 
capital). Vital signs were mentioned in two ways (yes, no), including the surgical techniques 
used. And the durations according to 3 modalities (less than 3 days, between 3-8 days, more 
than 8 days). The age will be grouped by interval of 10 years, with 10 groups of 11-20 years 
21-30 years. The dependent variables are: etiological diagnosis, complications and changes. 
The independent variables are: age, MPI score, pre-op duration, post-op duration, length of 
stay, onset of symptoms. The relationship between length of hospital stay and length of post-
op, pre-op and pre-hospital stay and time to hospital arrival was analyzed as well as the MPI 
severity score. Pearson's correlation with p<0.05 was used as the significance threshold and the 
correlation of complications and duration of management by Spearman's correlation to assess 
the relationship between sex, age group, complications and length of hospital stay. The 
correlation is estimated as perfect if r=1; very strong if r>0.8; strong if r [0.5-0.8]; medium if r 
[0.2-0.5] and low if r<0.2. A multiple linear regression will be done for the most significant 
correlations. The comparison of the means was made by the Z test (for samples >30), with α< 
0.05 as the significance threshold, and the student T test (Independent T Test) for variables 
with two modalities such as complication. The ANOVA test was used to cross-reference 
dependent and independent variables with more than 2 modalities, and the Pearson chi-square 
test for qualitative variables with etiological and demographic diagnoses. The results are 
presented on tables and graphs. The data are collected from the sheets and then entered into the 
Epi Info software and processed by the PSPP and SPSS 20, Software. 
Risk and benefit to study participants  
This study does not present any direct benefit to the participants. However, the study 
does provide a better understanding of the disease/condition studied in our community. 
Ethics of Study 
The work is carried out under the supervision of the Faculty's LABMES (Laboratory of 
Ethical Medicine and Societies). First we submitted the work protocol to LABMES, which 
after analysis and corrections gave us permission to request a letter from the vice deanery of 
the Faculty addressed to the head of the hospital. A coding system made with the first letters 
of patients' first and last names as well as the first digit of the admission date, was used to keep 
anonymity and the data was collected in the department itself, then stored on my personal 
online account Dropbox. 

7 
 
 
Informed Consent/Assent Process 
As it is a retrospective study we cannot have access to the patient for an informed 
consent. So we assumed that the head medical directory of the hospital gives us the permission 
to use the data information. 
Funding 
               This research did not receive any specific grant from funding agencies in the public, 
commercial, or not-for-profit sectors. 
Publication Policy 
No personal information will be disclosed and subjects will not be identified when the 
findings of the survey are published 
 
 
 
 
 
 

A 
 
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