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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidemiological description | Other | Description of the characteristics of Peritonitis in Haiti |
| 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 |
| 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 |
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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
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Sterman Toussaint, MD | Universite d'Etat d'Haiti | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axler JEAN PAUL | Port-au-Prince | Ouest | HT6140 | Haiti |
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| ID | Title | Description |
|---|---|---|
| FG000 | Population | The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sampling is probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of 19% . The standard error rate chosen was 5%. This allows us to estimate our sample at 88 with a confidence interval of 97%. our sample was adjusted to 20%.15 were excluded What makes 91 as the final sample.
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| ID | Title | Description |
|---|---|---|
| BG000 | Population | The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | To estimate the sample size, weconsidered the peritonitis prevalence of 19% . The standard error rate chosen was 5%. This allows us to estimate our sample at 88 with a confidence interval of 97%. our sample was adjusted to 20%.15 were excluded What makes 91 as the final sample. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate | Heart rate number of beats/min reported in the file entry for each patients | Posted | Mean | Standard Deviation | Beats/min | immediately after admission, up to 30 minutes |
|
24 hours in post-operation rooms
The adverse events were the cases of post-operative complications recorded during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Population | The study population is composed of all patients diagnosed, hospitalizedand operated on in the peritonitis ward during the study period. Samplingis probabilistic, simple random sampling. To estimate the sample size, weconsidered the peritonitis prevalence of an African study on the particularityof peritonitis in tropical environments, an environment that reflects our realityin ecological, demographic and epidemiological terms, namely 19% . Thestandard error rate chosen was 5%. This allows us to estimate our sample at88 with a confidence interval of 97%. Given the possibility of finding missingfiles at the State University Hospital of Haïti, our sample was adjusted to 20%(standard non-response rate). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative complications | Surgical and medical procedures | Complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Axler JEAN PAUL, Author | Université d'État d'Haïti | +50943776900 | jeanpaulaxler@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2019 | Jan 14, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| 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 |
| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Respiratory Rate | Respiratory rate number of cycle/min reported in the file of entry | For the other (11) patients we did not find any data relating to the respiratory rate. | Posted | Mean | Standard Deviation | Cycle/min | immediately after admission, up to 30 minutes |
|
|
|
| Primary | Temperature | Temperature in celsius reported in the file of entry | For the other (6) patients we did not find any data relating to the temperature | Posted | Mean | Standard Deviation | Celcius | immediately after admission, up to 30 minutes |
|
|
|
| Primary | Blood Pressure | Systolic Blood pressure in mmHg reported in the file of entry | For the other (21) patients we did not find any data relating to the systolic blood pressure. | Posted | Mean | Standard Deviation | Hg mm | immediately after admission, up to 30 minutes |
|
|
|
| Primary | Etiological Diagnosis | final diagnosis retained in the operating protocol | Not Posted | immediately post-surgery | Participants |
| Primary | Demographic Parameters | Age in years described in the admission file | Not Posted | during admission | Participants |
| Secondary | Onset of Symptoms | Days before coming at the hospital | We did not find information in the files on the onset of symptoms for 10 patients | Posted | Mean | Standard Deviation | days | 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 | We did not find information in the files on the delay in pre-op for 1 patient | Posted | Mean | Standard Deviation | days | 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 | We did not find information in the files on the delay in post-op for 1 patient | Posted | Mean | Standard Deviation | days | immediately after hospitalization |
|
|
|
| Secondary | Delay in Hospital | the time in days between the date of admission and the date of leaving the hospital | Posted | Mean | Standard Deviation | days | immediately after hospitalization |
|
|
|
| 3 |
| 91 |
| 21 |
| 91 |
| 0 |
| 91 |
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