Descriptive and Correlational Study of Peritonitis in Haiti.

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

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.

Study Overview

• Status: Completed
• Conditions: Peritonitis
• Intervention / Treatment: Other: Epidemiological description

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Haiti
  • Ouest
    • Port-au-Prince, Ouest, Haiti, HT6140
      • Axler JEAN PAUL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 82 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate number of beats/min reported in the file entry for each patients	immediately after admission, up to 30 minutes
Respiratory Rate	Respiratory rate number of cycle/min reported in the file of entry	immediately after admission, up to 30 minutes
Temperature	Temperature in celsius reported in the file of entry	immediately after admission, up to 30 minutes
Blood Pressure	Systolic Blood pressure in mmHg reported in the file of entry	immediately after admission, up to 30 minutes
Etiological Diagnosis	final diagnosis retained in the operating protocol	immediately post-surgery
Demographic Parameters	Age in years described in the admission file	during admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of Symptoms	Days before coming at the hospital	immediately after admission
Delay in Pre-op	the pre-operative time in days which describes the time between the date of the intervention and the date of admission	immediately post-surgery
Delay in Post-op	the time in days between the date of the intervention and the leaving of the patient at the hospital	immediately after hospitalization
Delay in Hospital	the time in days between the date of admission and the date of leaving the hospital	immediately after hospitalization

Collaborators and Investigators

• Sponsor: Universite d'Etat d'Haiti
• Investigators: Study Director: Sterman Toussaint, MD, Universite d'Etat d'Haiti

Publications and helpful links

Helpful Links

• Link of the protocol study, published in the international journal of Surgery protocol

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: November 23, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 1, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Peritoneal Diseases; Intraabdominal Infections; Peritonitis
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No