PeritonitisNCT04182217
Descriptive and Correlational Study of Peritonitis in Haiti.
An observational study of Peritonitis, run by Universite d'Etat d'Haiti at 1 site in Haiti.
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. Read more about this study
- Who is it for?
- Ages 11 to 82 years
- Conditions the study is for
- Peritonitis
- What is being tested?
- Epidemiological description
- How many people
- 91 participants
- Where
- 1 siteHaiti
- Study dates
- 10 Sep 2018to 1 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients with incomplete records.
- Cases of post-operative peritonitis.
- Patient under 10 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Peritonitis
- Being tested
- Epidemiological description
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological descriptionOther
Description of the characteristics of Peritonitis in Haiti
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate number of beats/min reported in the file entry for each patients
Measured: immediately after admission, up to 30 minutes
Respiratory Rate
Respiratory rate number of cycle/min reported in the file of entry
Measured: immediately after admission, up to 30 minutes
Temperature
Temperature in celsius reported in the file of entry
Measured: immediately after admission, up to 30 minutes
Blood Pressure
Systolic Blood pressure in mmHg reported in the file of entry
Measured: immediately after admission, up to 30 minutes
Etiological Diagnosis
final diagnosis retained in the operating protocol
Measured: immediately post-surgery
Demographic Parameters
Age in years described in the admission file
Measured: during admission
Secondary outcomes (4)
Onset of Symptoms
Days before coming at the hospital
Measured: 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
Measured: 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
Measured: immediately after hospitalization
Delay in Hospital
the time in days between the date of admission and the date of leaving the hospital
Measured: immediately after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start10 Sep 2018
- Primary completion20 Mar 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite d'Etat d'Haiti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JEAN PAUL Axler, Universite d'Etat d'Haiti
- Investigators
- Sterman Toussaint, MD, Study director, Universite d'Etat d'Haiti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182217
- Sponsor's protocol ID
- 01
- Status last verified
- Feb 2020
- First submitted
- 23 Nov 2019
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04182217
- Acronym / sponsor ID
- 01
- Conditions
- Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Universite d'Etat d'HaitiUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 11 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with incomplete records.
- Cases of post-operative peritonitis.
- Patient under 10 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiological descriptionDescription of the characteristics of Peritonitis in Haiti | Other | – |
Primary outcome
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
Respiratory Rate
Time frame: immediately after admission, up to 30 minutes
Respiratory rate number of cycle/min reported in the file of entry
Temperature
Time frame: immediately after admission, up to 30 minutes
Temperature in celsius reported in the file of entry
Blood Pressure
Time frame: immediately after admission, up to 30 minutes
Systolic Blood pressure in mmHg reported in the file of entry
Etiological Diagnosis
Time frame: immediately post-surgery
final diagnosis retained in the operating protocol
Demographic Parameters
Time frame: during admission
Age in years described in the admission file
4 secondary outcomes
Onset of Symptoms
Time frame: immediately after admission
Delay in Pre-op
Time frame: immediately post-surgery
Delay in Post-op
Time frame: immediately after hospitalization
Delay in Hospital
Time frame: immediately after hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Fecal Peritonitis, Secondary Peritonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sterman Toussaint, MD study director
Universite d'Etat d'Haiti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritonitis, run by Universite d'Etat d'Haiti at 1 site in Haiti.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: immediately after admission, up to 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.