Status:
UNKNOWN
Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Lead Sponsor:
Lasse Krogsbøll
Conditions:
Anal Fissure
Microbial Colonization
Eligibility:
All Genders
16+ years
Brief Summary
In this study, we will try to answer the following questions: 1. What are the salient features of the microbiota in chronic anal fissure? 2. Are these features associated with prognosis and response ...
Detailed Description
To allow rational planning of therapeutic trials of antimicrobial or biofilm degrading medical therapy, a better understanding of the microbiota of chronic anal fissures is needed. Previous studies ha...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Three samples will be included:
- Consecutive patients referred to the outpatient clinic at the Digestive Disease Centre, Bispebjerg Hospital in Denmark for botox injection for chronic anal fissure. Thus, the included patients will likely all have tried conservative treatment before referral, and are expected to represent a more homogeneous subset with longer standing disease, less spontaneous improvement, and a higher likelihood of being compliant with suggested therapy
- Consecutive patients with an indication for revision of the fissure and anal injection of botulinum toxin in general anaesthesia
- Healthy volunteers. These will be recruited among staff at the Digestive Disease Centre, Bispebjerg Hospital, Denmark.
- Samples 1 and 2 will not be independent, as patients from group 1 may be included in group 2 depending on the clinical course. No direct comparisons between these two groups are planned (see analysis section).
- Exclusion criteria
- Symptom duration of less than 8 weeks (groups 1 and 2)
- Known or suspected Crohn's disease
- Known or suspected active venereal disease.
Exclusion
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05405634
Start Date
September 1 2022
End Date
June 1 2023
Last Update
June 6 2022
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