About this trial
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Patients with chronic anal fissure with spasm of anal sphincter
Disqualifiers
• Inflammatory diseases of the colon
Pectenosis
Previous surgical interventions on the anal canal
IV grade internal and external hemorrhoids
Trial design
Parallel
Treatments tested in this trial
excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A
Procedure/Surgerypatients undergo excision of the fissure in combination with drug relaxation of the internal sphincter with botulinum toxin type A at a dosage of 40 units of action; an additional injection of platelet-rich plasma is added
Treatment groups
Trial outcomes
Primary outcomes
Anal sphincter insufficiency
Frequency of anal sphincter insufficiency according to the Wexner scale
Secondary outcomes
2-item pain intensity (P2)
Self reported pain intensity after the defecation and during the day after the surgical intervention. Each item is scored 0-10 (0 = no pain; 10 = pain as bad, as can can be).
Non-Healing Wound
Frequency of post-operative wound epithelialization
Profilometry /sphincterometry findings
Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry
Temporary disability
Duration of temporary disability
Sponsors and contacts
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