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Completed

NCT Number: NCT04182217

Descriptive and Correlational Study of Peritonitis in Haiti.

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.

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Key information

Age range

11 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Axler JEAN PAUL

Port-au-Prince, Ouest, HT6140, Haiti

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidemiological description

Other

Description of the characteristics of Peritonitis in Haiti

Primary outcomes

  1. Heart Rate

    Time frame: immediately after admission, up to 30 minutes

    Heart rate number of beats/min reported in the file entry for each patients

  2. Respiratory Rate

    Time frame: immediately after admission, up to 30 minutes

    Respiratory rate number of cycle/min reported in the file of entry

  3. Temperature

    Time frame: immediately after admission, up to 30 minutes

    Temperature in celsius reported in the file of entry

  4. Blood Pressure

    Time frame: immediately after admission, up to 30 minutes

    Systolic Blood pressure in mmHg reported in the file of entry

  5. Etiological Diagnosis

    Time frame: immediately post-surgery

    final diagnosis retained in the operating protocol

  6. Demographic Parameters

    Time frame: during admission

    Age in years described in the admission file

Secondary outcomes

  1. Onset of Symptoms

    Time frame: immediately after admission

    Days before coming at the hospital

  2. Delay in Pre-op

    Time frame: immediately post-surgery

    the pre-operative time in days which describes the time between the date of the intervention and the date of admission

  3. Delay in Post-op

    Time frame: immediately after hospitalization

    the time in days between the date of the intervention and the leaving of the patient at the hospital

  4. Delay in Hospital

    Time frame: immediately after hospitalization

    the time in days between the date of admission and the date of leaving the hospital

Sponsors and collaborators

Lead sponsor

Universite d'Etat d'Haiti

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2019
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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