Clinical trial NCT04182217: Descriptive and Correlational Study of Peritonitis in Haiti.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Lead sponsor: Universite d'Etat d'Haiti
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 91
Sex: ALL
Minimum age (years): 11
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is composed of all patients diagnosed, hospitalized and operated on in the peritonitis ward during the study period.

Sampling is probabilistic, simple random sampling. 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% . 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 the State University Hospital of Haïti, our sample was adjusted to 20% (standard non-response rate).

Brief summary: The primary objective:

To study the prevalence, etiology, and factors associated with the severity of peritonitis and its complications in the surgery department of the State University Hospital of Haiti.

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.

Detailed description: Generalized secondary peritonitis is one of the most common emergencies encountered in surgical departments . 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 . Delays in surgical management are conditions that increase mortality. 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 . It has been observed that classifying the severity of peritonitis has a major contribution to decision-making and improves management. Thus, 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) 6. 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 peritonitis to be predicted . 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-Haitian on 176 patients by Dr. Jacques Julmice, who presents the main etiologies of peritonitis over a 5-year period. And the other one carried out at the Albert Schweizer Hospital by Dr. Moise Aristide, still on the etiological factors of peritonitis. 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. Therefore, our study aims to explore the demographic, clinical and etiological factors of peritonitis in the main referral hospital in the metropolitan region of the country, as well as the time required for treatment and its relationship with the severity of the disease.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate
timeFrame: immediately after admission, up to 30 minutes
measure: Respiratory Rate
timeFrame: immediately after admission, up to 30 minutes
measure: Temperature
timeFrame: immediately after admission, up to 30 minutes
measure: Blood Pressure
timeFrame: immediately after admission, up to 30 minutes
measure: Etiological Diagnosis
timeFrame: immediately post-surgery
measure: Demographic Parameters
timeFrame: during admission
Secondary outcomes:
measure: Onset of Symptoms
timeFrame: immediately after admission
measure: Delay in Pre-op
timeFrame: immediately post-surgery
measure: Delay in Post-op
timeFrame: immediately after hospitalization
measure: Delay in Hospital
timeFrame: immediately after hospitalization
Other outcomes:
Locations:
city: Port-au-Prince
country: Haiti
facility: Axler JEAN PAUL
state: Ouest
Study officials:
affiliation: Universite d'Etat d'Haiti
name: Sterman Toussaint, MD
role: STUDY_DIRECTOR
References: