Descriptive and Correlational Study of Peritonitis in Haiti.

NCT04182217 | Completed Results

• 1 other identifier: 01
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritonitis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Onset of Symptoms

  immediately after admission

• Delay in Pre-op

  immediately post-surgery

• Delay in Post-op

  immediately after hospitalization

• Delay in Hospital

  immediately after hospitalization

Interventions

Epidemiological description OTHER

Description of the characteristics of Peritonitis in Haiti

Eligibility Criteria

• Age: 11 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Patients with incomplete records.
• Cases of post-operative peritonitis.
• Patient under 10 years of age

Sponsors & Collaborators

• Universite d'Etat d'Haiti: lead

Study Sites (1)

Axler JEAN PAUL

Port-au-Prince, Ouest, HT6140, Haiti

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Axler JEAN PAUL, Author
• Organization: Université d'État d'Haïti

jeanpaulaxler@hotmail.com

+50943776900

Study Officials

• Sterman Toussaint, MD

  Universite d'Etat d'Haiti

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student

Study Record Dates

• First Submitted: November 23, 2019
• First Posted: December 2, 2019
• Study Start: September 10, 2018
• Primary Completion: March 20, 2019
• Study Completion: October 1, 2019
• Last Updated: February 12, 2020
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

HA (1)