NCT05736926

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

February 18, 2023

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of anal fissure among covid -19 survivors

    how many patients developed anal fissure among total patients

    6 months

Secondary Outcomes (1)

  • risk factors associated with development of anal fissure

    6 months - 1year

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All COVID-19 survivors who developed anal fissure

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who didn't experience anal pain or anal fissure,
  • Patients who died were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Fissure in AnoCoronavirus Infections

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant and lecturer of general surgery

Study Record Dates

First Submitted

February 18, 2023

First Posted

February 21, 2023

Study Start

September 1, 2020

Primary Completion

October 30, 2020

Study Completion

November 30, 2020

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations