Anal FissureNCT05736926
Anal Fissure Among Survivors of COVID-19 Virus Infection.
An observational study of Anal Fissure and Corona Virus Infection, run by Mansoura University at 1 site in Egypt.
Trial summary
Background Anal fissure is one of the most common anorectal problems. After an outbreak of coronavirus disease (COVID-19) has rapidly spread from China to almost all over the world, it nearly affected all countries. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Anal Fissure, Corona Virus Infection
- How many people
- 176 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Nov 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All COVID-19 survivors who developed anal fissure
Who may be able to join
- Patients of both genders
- Aging between 20-70 years
- With or without associated co-morbidities
- Those who received treatment for COVID-19 infection, were discharged home safely, Those who presented with anal fissure during the follow up were included.
Who cannot join
- Patients who didn't experience anal pain or anal fissure,
- Patients who died were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anal Fissure Among Survivors of COVID-19 Virus Infection, Risk Factors and Outcome. A Single Center Experience.
Background Anal fissure is one of the most common anorectal problems. After an outbreak of coronavirus disease (COVID-19) has rapidly spread from China to almost all over the world, it nearly affected all countries. In spite of its typical presentation in the form of fever, cough, myalgia, fatigue and pneumonia, other GIT manifestations were reported. We found some of COVID-19 survivors who had complained from anal fissure problem. The aim of this study was to report the prevalence of acute anal fissure among COVID-19 patients, its possible risk factors and outcome.
Methods This is a retrospective cross-sectional study which was conducted over three months from the start of September 2020 to the end of November 2020 at Mansoura university isolation hospital, on COVID-19 patients' who were diagnosed with anal fissure. Those who survived and were discharged home safely were telephone called to pick up whether they suffered from any symptoms of anal pain, difficulty in defecation suggesting anal fissure, in order to identify their outcomes, the risk factors for anal fissure development and how they were managed.
Read more
Results A total of 176 patients were enrolled in this study. Patients were categorized into two groups. The first group included patients who developed anal fissure (n=65) and the 2nd group included patients who did not develop anal fissure (n=111). No significant difference was noted in demographic data apart from the age which was younger in the fissure group. The incidence of anal fissure was 36.9% of total population. The majority of patients' anal fissure problem resolved spontaneously after patients improved from the COVID symptoms without receiving any treatment (43.1%).
Conclusion Anal fissure is quite common problem after COVID-19. Young and middle age patients are more vulnerable to develop anal fissure after COVID-19 infection.
Read the detailed description
Methods Study design This is a retrospective cross-sectional study which was conducted over three months from the start of September 2020 to the end of November 2020 at Mansoura university isolation hospital, on COVID-19 patients' who were diagnosed to have anal fissure. Mansoura isolation hospital is a tertiary referral center that admits COVID -19 patients. Patient who had experienced any symptoms that suggests COVID-19 infection and their nasal swab tested PCR positive were admitted. Also patients with CT chest findings that suggest COVID-19 infection were admitted.
The study protocol was approved by the Institutional Review Board (IRB) of Mansoura University (IRB No. R.21.07.1383). Informed consents were obtained from the patients.
Eligibility criteria Patients of both genders aging between 20-70 years with or without associated co-morbidities who received treatment for COVID-19 infection, were discharged home safely, and presented with anal fissure during the follow up were included. Patients who didn't experience anal pain or anal fissure, and patients who died were excluded from this study.
Patient interview By checking the Electronic medical records (EMR) during those 3 months, all patients' data was addressed and those who survived and were discharged home safely were telephone called to pick up whether they suffered from any symptoms of anal pain, difficulty in defecation suggesting anal fissure. Trying to identify their outcomes, the risk factors for anal fissure development and how they were managed. We telephoned about 350 patients, 176 replied to us while 174 didn't answer.
Those who suffered from anal pain problems were advised to come to our colorectal outpatient clinic (OPC) to be examined to make sure of the diagnosis. But, because of the pandemic situation, no patient came to the OPC. Further telephone calls were conducted to those who were diagnosed with anal fissure to ask about their outcomes, to pick up how many of them were managed medically or their symptoms resolved spontaneously or needed surgical interference.
All patient recorded data including; age, sex, the associated co-morbidities, and the degree of severity of infection, respiratory or GIT symptoms and the need for oxygen therapy were collected. Other symptoms as fever, loss of smell and/or taste sensation, constipation or diarrhea and also the duration of these symptoms were checked. Additionally, the investigations that were conducted either laboratory or radiological.
- Conditions
- Anal Fissure, Corona Virus Infection
- Medical subject headings
- Fissure in Ano, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of anal fissure among covid -19 survivors
how many patients developed anal fissure among total patients
Measured: 6 months
Secondary outcomes (1)
risk factors associated with development of anal fissure
possible causes of fissure among this group
Measured: 6 months - 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736926
- Sponsor's protocol ID
- 1234
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Fissure Among Survivors of COVID-19 Virus Infection, Risk Factors and Outcome. A Single Center Experience.
- ClinicalTrials.gov ID
- NCT05736926
- Acronym / sponsor ID
- 1234
- Conditions
- Anal Fissure, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 21 Feb 2023 (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.
Background Anal fissure is one of the most common anorectal problems. After an outbreak of coronavirus disease (COVID-19) has rapidly spread from China to almost all over the world, it nearly affected all countries. In spite of its typical presentation in the form of fever, cough, myalgia, fatigue and pneumonia, other GIT manifestations were reported. We found some of COVID-19 survivors who had complained from anal fissure problem. The aim of this study was to report the prevalence of acute anal fissure among COVID-19 patients, its possible risk factors and outcome.
Methods This is a retrospective cross-sectional study which was conducted over three months from the start of September 2020 to the end of November 2020 at Mansoura university isolation hospital, on COVID-19 patients' who were diagnosed with anal fissure. Those who survived and were discharged home safely were telephone called to pick up whether they suffered from any symptoms of anal pain, difficulty in defecation suggesting anal fissure, in order to identify their outcomes, the risk factors for anal fissure development and how they were managed.
Results A total of 176 patients were enrolled in this study. Patients were categorized into two groups. The first group included patients who developed anal fissure (n=65) and the 2nd group included patients who did not develop anal fissure (n=111). No significant difference was noted in demographic data apart from the age which was younger in the fissure group. The incidence of anal fissure was 36.9% of total population. The majority of patients' anal fissure problem resolved spontaneously after patients improved from the COVID symptoms without receiving any treatment (43.1%).
Conclusion Anal fissure is quite common problem after COVID-19. Young and middle age patients are more vulnerable to develop anal fissure after COVID-19 infection.
Detailed description
Methods Study design This is a retrospective cross-sectional study which was conducted over three months from the start of September 2020 to the end of November 2020 at Mansoura university isolation hospital, on COVID-19 patients' who were diagnosed to have anal fissure. Mansoura isolation hospital is a tertiary referral center that admits COVID -19 patients. Patient who had experienced any symptoms that suggests COVID-19 infection and their nasal swab tested PCR positive were admitted. Also patients with CT chest findings that suggest COVID-19 infection were admitted.
The study protocol was approved by the Institutional Review Board (IRB) of Mansoura University (IRB No. R.21.07.1383). Informed consents were obtained from the patients.
Eligibility criteria Patients of both genders aging between 20-70 years with or without associated co-morbidities who received treatment for COVID-19 infection, were discharged home safely, and presented with anal fissure during the follow up were included. Patients who didn't experience anal pain or anal fissure, and patients who died were excluded from this study.
Patient interview By checking the Electronic medical records (EMR) during those 3 months, all patients' data was addressed and those who survived and were discharged home safely were telephone called to pick up whether they suffered from any symptoms of anal pain, difficulty in defecation suggesting anal fissure. Trying to identify their outcomes, the risk factors for anal fissure development and how they were managed. We telephoned about 350 patients, 176 replied to us while 174 didn't answer.
Those who suffered from anal pain problems were advised to come to our colorectal outpatient clinic (OPC) to be examined to make sure of the diagnosis. But, because of the pandemic situation, no patient came to the OPC. Further telephone calls were conducted to those who were diagnosed with anal fissure to ask about their outcomes, to pick up how many of them were managed medically or their symptoms resolved spontaneously or needed surgical interference.
All patient recorded data including; age, sex, the associated co-morbidities, and the degree of severity of infection, respiratory or GIT symptoms and the need for oxygen therapy were collected. Other symptoms as fever, loss of smell and/or taste sensation, constipation or diarrhea and also the duration of these symptoms were checked. Additionally, the investigations that were conducted either laboratory or radiological.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All COVID-19 survivors who developed anal fissure
Key inclusion criteria (4 listed)
- Patients of both genders
- Aging between 20-70 years
- With or without associated co-morbidities
- Those who received treatment for COVID-19 infection, were discharged home safely, Those who presented with anal fissure during the follow up were included.
Key exclusion criteria (2 listed)
- Patients who didn't experience anal pain or anal fissure,
- Patients who died were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of anal fissure among covid -19 survivors
Time frame: 6 months
how many patients developed anal fissure among total patients
1 secondary outcome
risk factors associated with development of anal fissure
Time frame: 6 months - 1year
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 24 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anal Fissure and Corona Virus Infection, run by Mansoura 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 24 Feb 2023. 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?
incidence of anal fissure among covid -19 survivors (time frame: 6 months). 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 24 Feb 2023.