Trial Outcomes & Findings for Descriptive and Correlational Study of Peritonitis in Haiti. (NCT NCT04182217)

NCT ID: NCT04182217

Last Updated: 2020-02-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 91 participants
• Primary outcome timeframe: immediately after admission, up to 30 minutes
• Results posted on: 2020-02-12

Participant Flow

Participant milestones

Measure	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).
Overall Study STARTED	91
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	Population n=91 Participants 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).
Age, Categorical <=18 years	30 Participants n=91 Participants • 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.
Age, Categorical Between 18 and 65 years	58 Participants n=91 Participants • 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.
Age, Categorical >=65 years	3 Participants n=91 Participants • 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.
Age, Continuous	27.29 Years STANDARD_DEVIATION 13.28 • n=91 Participants
Sex: Female, Male Female	33 Participants n=91 Participants
Sex: Female, Male Male	58 Participants n=91 Participants
Region of Enrollment Haiti	91 participants n=91 Participants

PRIMARY outcome

Timeframe: immediately after admission, up to 30 minutes

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

Outcome measures

Measure

Population n=86 Participants 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).

Heart Rate

108.18 Beats/min Standard Deviation 19.66

PRIMARY outcome

Timeframe: immediately after admission, up to 30 minutes

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

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

Outcome measures

Measure

Population n=80 Participants 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).

Respiratory Rate

28.58 Cycle/min Standard Deviation 8.51

PRIMARY outcome

Timeframe: immediately after admission, up to 30 minutes

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

Temperature in celsius reported in the file of entry

Outcome measures

Measure

Population n=85 Participants 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).

Temperature

37.52 Celcius Standard Deviation 1.1

PRIMARY outcome

Timeframe: immediately after admission, up to 30 minutes

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

Systolic Blood pressure in mmHg reported in the file of entry

Outcome measures

Measure

Population n=69 Participants 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).

Blood Pressure

110.93 Hg mm Standard Deviation 14.86

PRIMARY outcome

Timeframe: immediately post-surgery

final diagnosis retained in the operating protocol

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: during admission

Age in years described in the admission file

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: immediately after admission

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

Days before coming at the hospital

Outcome measures

Measure

Population n=81 Participants 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).

Onset of Symptoms

6.9 days Standard Deviation 8.1

SECONDARY outcome

Timeframe: immediately post-surgery

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

the pre-operative time in days which describes the time between the date of the intervention and the date of admission

Outcome measures

Measure

Population n=90 Participants 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).

Delay in Pre-op

3.73 days Standard Deviation 3.61

SECONDARY outcome

Timeframe: immediately after hospitalization

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

the time in days between the date of the intervention and the leaving of the patient at the hospital

Outcome measures

Measure

Population n=90 Participants 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).

Delay in Post-op

9.19 days Standard Deviation 10.93

SECONDARY outcome

Timeframe: immediately after hospitalization

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

Outcome measures

Measure

Population n=91 Participants 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).

Delay in Hospital

12.82 days Standard Deviation 11.66

Adverse Events

Population

Serious events: 21 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure

Population n=91 participants at risk 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).

Surgical and medical procedures Post-operative complications

23.1% 21/91 • Number of events 21 • 24 hours in post-operation rooms The adverse events were the cases of post-operative complications recorded during the study.

Other adverse events

Adverse event data not reported

Additional Information

Axler JEAN PAUL, Author

Université d'État d'Haïti

Phone: +50943776900

Email: jeanpaulaxler@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place