Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05736926 |
| Other study ID # |
1234 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
November 30, 2020 |
Study information
| Verified date |
February 2023 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
