Acute AbdomenNCT05295251
The Commonest Medical, Surgical, and Oncological Causes of Acute Abdomen in Adults With COVID-19. A Prospective Observational Study.
An observational study of Acute Abdomen, run by Zagazig University at 1 site in Egypt.
Trial summary
Coronaviruses are a large family of viruses that can cause mild to severe respiratory infections. 2019-nCoV is a novel coronavirus that was discovered in Wuhan, China. Since its discovery in humans in late 2019, it has had a global, rapid spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen
- What is being tested?
- medical ,oncological and surgical treatment of cases of acute abdomen
- How many people
- 910 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients > 18 years of age, both sexes, admitted to the emergency department or already admitted but complaining of an acute abdomen, and diagnosed with COVID-19 using a thoracic computed tomography (CT) scan and/or reverse transcription polymerase chain reaction (RT-PCR) of SARS-CoV-2 RNA, as per the Institute Pasteur protocol and WHO technical guidelines [8]. Patients younger than 18 years of age and those who were not confirmed to be COVID-19 positive were excluded from the study. All patients who underwent chest computed tomography (CT) and a comprehensive panel of routine laboratory tests, which included a complete blood count, urinalysis, blood biochemistry, and blood coagulation function.
Who may be able to join
- >18 years
- male and female
- covid-19 positive
- acute abdomen
Who cannot join
- < 18 years
- unsure diagnosis of covid-19
Trial locations and contacts
1 site in 1 country.
About this study
Coronaviruses are a large family of viruses that can cause mild to severe respiratory infections. 2019-nCoV is a novel coronavirus that was discovered in Wuhan, China. Since its discovery in humans in late 2019, it has had a global, rapid spread. Dry cough, fever, and fatigue are the most common symptoms in the first two to 14 days after exposure.
At the moment, it is unknown how common gastrointestinal symptoms are. However, COVID-19's initial clinical presentations have become more evident as the pandemic has progressed and case data has been gathered, and literature suggests that digestive symptoms are prevalent .
Read more
In a recent systematic review and meta-analysis of 47 studies involving 10,890 patients with COVID-19, the pooled prevalence of gastrointestinal symptoms were 7.7 % for diarrhea, 7.8% for nausea/vomiting, and 2.7% for abdominal pain. Only a few cases of isolated abdominal pain have been reported.
A wide range of diseases can cause acute abdominal pain, and diagnosing them can be difficult. The examining physician should prioritize life-threatening conditions that may necessitate immediate surgical intervention with such a broad differential diagnosis to avoid further mortality or morbidity. The objective of this study was to determine the characteristics, incidence, severity and of acute abdominal pain (medical and surgical causes) during the COVID-19 pandemic.
Read the detailed description
Coronaviruses are a large family of viruses that can cause mild to severe respiratory infections. 2019-nCoV is a novel coronavirus that was discovered in Wuhan, China. Since its discovery in humans in late 2019, it has had a global, rapid spread. Dry cough, fever, and fatigue are the most common symptoms in the first two to 14 days after exposure.
At the moment, it is unknown how common gastrointestinal symptoms are. However, COVID-19's initial clinical presentations have become more evident as the pandemic has progressed and case data has been gathered, and literature suggests that digestive symptoms are prevalent .
In a recent systematic review and meta-analysis of 47 studies involving 10,890 patients with COVID-19, the pooled prevalence of gastrointestinal symptoms were 7.7 % for diarrhea, 7.8% for nausea/vomiting, and 2.7% for abdominal pain. Only a few cases of isolated abdominal pain have been reported.
A wide range of diseases can cause acute abdominal pain, and diagnosing them can be difficult. The examining physician should prioritize life-threatening conditions that may necessitate immediate surgical intervention with such a broad differential diagnosis to avoid further mortality or morbidity. The objective of this study was to determine the characteristics, incidence, severity and of acute abdominal pain (medical and surgical causes) during the COVID-19 pandemic.
Acute abdominal pain in COVID-19 patients poses a diagnostic quandary for clinicians. Delays in treating an acute abdomen can lead to severe complications and even death. In contrast, performing unnecessary surgery on COVID-19 patients results in increased morbidity and mortality, increased strain on healthcare resources, and an increased risk of exposure for healthcare workers in operative fields. This study aimed to determine the characteristics, incidence and severity, and of various medical and surgical causes of acute abdomen in COVID-19. According to our study, gastritis is the most common medical cause of acute abdomen (19.2%). While acute appendicitis (42.4%), acute cholecystitis (11%), and biliary colic (9.8%) are the most frequently encountered surgical causes of acute abdomen, acute pancreatitis occurred in (3%) of cases and mainly was benign in course. Except for acute appendicitis, intestinal ischemia and liver abscesses, the severity of all causes of acute abdomen did not worsen.
Abdominal pain is a less frequent symptom of COVID-19 infection than anorexia, nausea/vomiting, or diarrhea. Abdominal pain is prevalent in 3.9-6.8% of the population .
- Conditions
- Acute Abdomen
- Being tested
- medical ,oncological and surgical treatment of cases of acute abdomen
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical ,oncological and surgical treatment of cases of acute abdomenOther
medical treatment and surgical intervention during covid-19 pandemic
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristic, severity and incidence of acute abdomen
incidence in %
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 May 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer Alsaied Alnaimy, Zagazig University
- Investigators
- Alnaimy A alnaimy, Phd, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295251
- Sponsor's protocol ID
- acute abdomen in covid
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Commonest Medical, Surgical, and Oncological Causes of Acute Abdomen in Adults With COVID-19. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05295251
- Acronym / sponsor ID
- acute abdomen in covid
- Conditions
- Acute Abdomen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronaviruses are a large family of viruses that can cause mild to severe respiratory infections. 2019-nCoV is a novel coronavirus that was discovered in Wuhan, China. Since its discovery in humans in late 2019, it has had a global, rapid spread. Dry cough, fever, and fatigue are the most common symptoms in the first two to 14 days after exposure.
At the moment, it is unknown how common gastrointestinal symptoms are. However, COVID-19's initial clinical presentations have become more evident as the pandemic has progressed and case data has been gathered, and literature suggests that digestive symptoms are prevalent .
In a recent systematic review and meta-analysis of 47 studies involving 10,890 patients with COVID-19, the pooled prevalence of gastrointestinal symptoms were 7.7 % for diarrhea, 7.8% for nausea/vomiting, and 2.7% for abdominal pain. Only a few cases of isolated abdominal pain have been reported.
A wide range of diseases can cause acute abdominal pain, and diagnosing them can be difficult. The examining physician should prioritize life-threatening conditions that may necessitate immediate surgical intervention with such a broad differential diagnosis to avoid further mortality or morbidity. The objective of this study was to determine the characteristics, incidence, severity and of acute abdominal pain (medical and surgical causes) during the COVID-19 pandemic.
Detailed description
Coronaviruses are a large family of viruses that can cause mild to severe respiratory infections. 2019-nCoV is a novel coronavirus that was discovered in Wuhan, China. Since its discovery in humans in late 2019, it has had a global, rapid spread. Dry cough, fever, and fatigue are the most common symptoms in the first two to 14 days after exposure.
At the moment, it is unknown how common gastrointestinal symptoms are. However, COVID-19's initial clinical presentations have become more evident as the pandemic has progressed and case data has been gathered, and literature suggests that digestive symptoms are prevalent .
In a recent systematic review and meta-analysis of 47 studies involving 10,890 patients with COVID-19, the pooled prevalence of gastrointestinal symptoms were 7.7 % for diarrhea, 7.8% for nausea/vomiting, and 2.7% for abdominal pain. Only a few cases of isolated abdominal pain have been reported.
A wide range of diseases can cause acute abdominal pain, and diagnosing them can be difficult. The examining physician should prioritize life-threatening conditions that may necessitate immediate surgical intervention with such a broad differential diagnosis to avoid further mortality or morbidity. The objective of this study was to determine the characteristics, incidence, severity and of acute abdominal pain (medical and surgical causes) during the COVID-19 pandemic.
Acute abdominal pain in COVID-19 patients poses a diagnostic quandary for clinicians. Delays in treating an acute abdomen can lead to severe complications and even death. In contrast, performing unnecessary surgery on COVID-19 patients results in increased morbidity and mortality, increased strain on healthcare resources, and an increased risk of exposure for healthcare workers in operative fields. This study aimed to determine the characteristics, incidence and severity, and of various medical and surgical causes of acute abdomen in COVID-19. According to our study, gastritis is the most common medical cause of acute abdomen (19.2%). While acute appendicitis (42.4%), acute cholecystitis (11%), and biliary colic (9.8%) are the most frequently encountered surgical causes of acute abdomen, acute pancreatitis occurred in (3%) of cases and mainly was benign in course. Except for acute appendicitis, intestinal ischemia and liver abscesses, the severity of all causes of acute abdomen did not worsen.
Abdominal pain is a less frequent symptom of COVID-19 infection than anorexia, nausea/vomiting, or diarrhea. Abdominal pain is prevalent in 3.9-6.8% of the population .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients > 18 years of age, both sexes, admitted to the emergency department or already admitted but complaining of an acute abdomen, and diagnosed with COVID-19 using a thoracic computed tomography (CT) scan and/or reverse transcription polymerase chain reaction (RT-PCR) of SARS-CoV-2 RNA, as per the Institute Pasteur protocol and WHO technical guidelines [8]. Patients younger than 18 years of age and those who were not confirmed to be COVID-19 positive were excluded from the study. All patients who underwent chest computed tomography (CT) and a comprehensive panel of routine laboratory tests, which included a complete blood count, urinalysis, blood biochemistry, and blood coagulation function.
Key inclusion criteria (4 listed)
- >18 years
- male and female
- covid-19 positive
- acute abdomen
Key exclusion criteria (2 listed)
- < 18 years
- unsure diagnosis of covid-19
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 |
|---|---|---|
| medical ,oncological and surgical treatment of cases of acute abdomenmedical treatment and surgical intervention during covid-19 pandemic | Other | – |
Primary outcome
characteristic, severity and incidence of acute abdomen
Time frame: 2 years
incidence in %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Alnaimy A alnaimy, Phd principal investigator
Zagazig University
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 Acute Abdomen, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 2 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 7 Sep 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
characteristic, severity and incidence of acute abdomen (time frame: 2 years). 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 7 Sep 2022.