RecruitingNot ApplicableNCT07268261
Combined Method of Surgical Treatment of Anal Fissure
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
Enrollment
122 participants
Start Date
Sep 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria1
- Patients with chronic anal fissure with spasm of anal sphincter
Exclusion Criteria13
- Inflammatory diseases of the colon
- Pectenosis
- Previous surgical interventions on the anal canal
- IV grade internal and external hemorrhoids
- Rectal fistula
- Severe somatic diseases at the decompensation stage
- Pregnancy and lactation
- Anal sphincter insufficiency
- Chronic paraproctitis
- Individual intolerance and hypersensitivity to botulinum toxin
- Myasthenia gravis and myasthenic syndromes
- History of allergic reaction to anticoagulants.
- Blood diseases (thrombocytopenia, splenomegaly, etc.)
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Interventions
PROCEDUREexcision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A
patients 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
Locations(1)
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NCT07268261