Descriptive and Correlational Study of Peritonitis in Haiti.

• Sponsor: Universite d'Etat d'Haiti (Other)
• Overall Status: Completed
• CT.gov ID: NCT04182217
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis	Other: Epidemiological description

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

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Mar 20, 2019
• Actual Study Completion Date: Oct 1, 2019

Outcome Measures

Primary Outcome Measures

1. Heart Rate [immediately after admission, up to 30 minutes]

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

2. Respiratory Rate [immediately after admission, up to 30 minutes]

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

3. Temperature [immediately after admission, up to 30 minutes]

   Temperature in celsius reported in the file of entry

4. Blood Pressure [immediately after admission, up to 30 minutes]

   Systolic Blood pressure in mmHg reported in the file of entry

5. Etiological Diagnosis [immediately post-surgery]

   final diagnosis retained in the operating protocol

6. Demographic Parameters [during admission]

   Age in years described in the admission file

Secondary Outcome Measures

1. Onset of Symptoms [immediately after admission]

   Days before coming at the hospital

2. Delay in Pre-op [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 [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 [immediately after hospitalization]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 82 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Axler JEAN PAUL	Port-au-Prince	Ouest	Haiti	HT6140

Sponsors and Collaborators

• Universite d'Etat d'Haiti

Investigators

• Study Director: Sterman Toussaint, MD, Universite d'Etat d'Haiti

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2019

More Information

Additional Information:

• Link of the protocol study, published in the international journal of Surgery protocol

Publications

None provided.

• Responsible Party: JEAN PAUL Axler, Medical Student, Universite d'Etat d'Haiti
• ClinicalTrials.gov Identifier: NCT04182217
• Other Study ID Numbers: 01
• First Posted: Dec 2, 2019
• Last Update Posted: Feb 12, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peritonitis

Study Results

Participant Flow

Arm/Group Title	Population
Arm/Group Description	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).
Period Title: Overall Study
STARTED	91
COMPLETED	91
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Population
Arm/Group Description	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).
Overall Participants	91
Age (Count of Participants)
<=18 years	30 33%
Between 18 and 65 years	58 63.7%
>=65 years	3 3.3%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	27.29 (13.28)
Sex: Female, Male (Count of Participants)
Female	33 36.3%
Male	58 63.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Haiti	91 100%

Outcome Measures

1. Primary Outcome

Title	Heart Rate
Description	Heart rate number of beats/min reported in the file entry for each patients
Time Frame	immediately after admission, up to 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	86
Mean (Standard Deviation) [Beats/min]	108.18 (19.66)

2. Primary Outcome

Title	Respiratory Rate
Description	Respiratory rate number of cycle/min reported in the file of entry
Time Frame	immediately after admission, up to 30 minutes

Outcome Measure Data

Analysis Population Description

For the other (11) patients we did not find any data relating to the respiratory rate.

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	80
Mean (Standard Deviation) [Cycle/min]	28.58 (8.51)

3. Primary Outcome

Title	Temperature
Description	Temperature in celsius reported in the file of entry
Time Frame	immediately after admission, up to 30 minutes

Outcome Measure Data

Analysis Population Description

For the other (6) patients we did not find any data relating to the temperature

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	85
Mean (Standard Deviation) [Celcius]	37.52 (1.1)

4. Primary Outcome

Title	Blood Pressure
Description	Systolic Blood pressure in mmHg reported in the file of entry
Time Frame	immediately after admission, up to 30 minutes

Outcome Measure Data

Analysis Population Description

For the other (21) patients we did not find any data relating to the systolic blood pressure.

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	69
Mean (Standard Deviation) [Hg mm]	110.93 (14.86)

5. Primary Outcome

Title	Etiological Diagnosis
Description	final diagnosis retained in the operating protocol
Time Frame	immediately post-surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Primary Outcome

Title	Demographic Parameters
Description	Age in years described in the admission file
Time Frame	during admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Onset of Symptoms
Description	Days before coming at the hospital
Time Frame	immediately after admission

Outcome Measure Data

Analysis Population Description

We did not find information in the files on the onset of symptoms for 10 patients

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	81
Mean (Standard Deviation) [days]	6.9 (8.1)

8. Secondary Outcome

Title	Delay in Pre-op
Description	the pre-operative time in days which describes the time between the date of the intervention and the date of admission
Time Frame	immediately post-surgery

Outcome Measure Data

Analysis Population Description

We did not find information in the files on the delay in pre-op for 1 patient

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	90
Mean (Standard Deviation) [days]	3.73 (3.61)

9. Secondary Outcome

Title	Delay in Post-op
Description	the time in days between the date of the intervention and the leaving of the patient at the hospital
Time Frame	immediately after hospitalization

Outcome Measure Data

Analysis Population Description

We did not find information in the files on the delay in post-op for 1 patient

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	90
Mean (Standard Deviation) [days]	9.19 (10.93)

10. Secondary Outcome

Title	Delay in Hospital
Description	the time in days between the date of admission and the date of leaving the hospital
Time Frame	immediately after hospitalization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Population
Arm/Group Description	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).
Measure Participants	91
Mean (Standard Deviation) [days]	12.82 (11.66)

Adverse Events

Time Frame	24 hours in post-operation rooms
Adverse Event Reporting Description	The adverse events were the cases of post-operative complications recorded during the study.
Arm/Group Title	Population
Arm/Group Description	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).
All Cause Mortality
	Population
	Affected / at Risk (%)	# Events
Total	3/91 (3.3%)
Serious Adverse Events
	Population
	Affected / at Risk (%)	# Events
Total	21/91 (23.1%)
Surgical and medical procedures
Post-operative complications	21/91 (23.1%)	21
Other (Not Including Serious) Adverse Events
	Population
	Affected / at Risk (%)	# Events
Total	0/91 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.