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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04182217
Other study ID # 01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2018
Est. completion date October 1, 2019

Study information

Verified date February 2020
Source Universite d'Etat d'Haiti
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date October 1, 2019
Est. primary completion date March 20, 2019
Accepts healthy volunteers No
Gender All
Age group 11 Years to 82 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Epidemiological description
Description of the characteristics of Peritonitis in Haiti

Locations

Country Name City State
Haiti Axler JEAN PAUL Port-au-Prince Ouest

Sponsors (1)

Lead Sponsor Collaborator
Universite d'Etat d'Haiti

Country where clinical trial is conducted

Haiti, 

Outcome

Type Measure Description Time frame Safety issue
Primary Heart Rate Heart rate number of beats/min reported in the file entry for each patients immediately after admission, up to 30 minutes
Primary Respiratory Rate Respiratory rate number of cycle/min reported in the file of entry immediately after admission, up to 30 minutes
Primary Temperature Temperature in celsius reported in the file of entry immediately after admission, up to 30 minutes
Primary Blood Pressure Systolic Blood pressure in mmHg reported in the file of entry immediately after admission, up to 30 minutes
Primary Etiological Diagnosis final diagnosis retained in the operating protocol immediately post-surgery
Primary Demographic Parameters Age in years described in the admission file during admission
Secondary Onset of Symptoms Days before coming at the hospital immediately after admission
Secondary 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
Secondary 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
Secondary Delay in Hospital the time in days between the date of admission and the date of leaving the hospital immediately after hospitalization
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