Anorectal manometry: techniques and clinical applications.
J M Jorge, S D Wexner
https://pubmed.ncbi.nlm.nih.gov/8351556Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07268261
Combined Method of Surgical Treatment of Anal Fissure
Led by State Scientific Centre of Coloproctology, Russian Federation · Updated on 2025-12-05
122
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatment options for patients with chronic anal fissure, a painful rupture of the anal canal mucous membrane lasting over two months and resistant to non-surgical treatments. This condition mainly affects young and able-bodied adults and is caused by spasms of the internal anal sphincter muscle. The study aims to improve treatment outcomes by reducing the frequency and duration of anal sphincter insufficiency after relieving these spasms. Participants will undergo excision of the anal fissure combined with relaxation of the internal sphincter using botulinum toxin type A. The treatment involves injecting 40 units of botulinum toxin into the internal anal sphincter at four specific locations. The study compares this combined approach to similar treatment methods and includes an additional injection of platelet-rich plasma. Patients are randomized into either the main group or control group, both receiving the same interventions. During the trial, researchers will monitor anal sphincter insufficiency over 60 days as the primary outcome. Secondary outcomes include pain intensity, wound healing, sphincter function measurements, temporary disability, and disease relapse, assessed at various intervals up to one year. Participants will be closely observed throughout these periods with clinical evaluations to track treatment effects and safety.
CONDITIONS
Brief Title
Combined Method of Surgical Treatment of Anal Fissure
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with chronic anal fissure accompanied by spasm of the anal sphincter
- Aged between 18 and 70 years
- All genders are eligible
You will not qualify if you...
- Inflammatory diseases of the colon, including pectenosis
- Previous surgical interventions on the anal canal
- Grade IV internal and external hemorrhoids
- Rectal fistula
- Severe somatic diseases at the decompensation stage
- Pregnancy and lactation
- Anal sphincter insufficiency
- Chronic paraproctitis
- Individual intolerance or hypersensitivity to botulinum toxin
- Myasthenia gravis and related syndromes
- History of allergic reaction to anticoagulants
- Blood diseases such as thrombocytopenia or splenomegaly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to 60 days
Participants undergo excision of the anal fissure with injections of botulinum toxin A to relax the internal sphincter.
Approximately 4 visits on days 15, 30, 45, and 60
Trial Site Locations
Total: 1 location
1
SSCCRussia
Moscow, Russia, 123423
Actively Recruiting
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Research Team
E
Evgeny E. Zharkov, MD
E
Ekaterina Yu. Lebedeva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Etiology and management of fecal incontinence.
J M Jorge, S D Wexner
https://pubmed.ncbi.nlm.nih.gov/8416784Non surgical therapy for anal fissure.
Richard L Nelson, Kathryn Thomas, Jenna Morgan...
https://pubmed.ncbi.nlm.nih.gov/22336789Effect of delivery on anal sphincter morphology and function.
J Zetterström, A Mellgren, L L Jensen...
https://pubmed.ncbi.nlm.nih.gov/10528760Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry.
P Delechenaut, A M Leroi, J Weber...
https://pubmed.ncbi.nlm.nih.gov/1511644Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials.
H-L Chen, X-B Woo, H-S Wang...
https://pubmed.ncbi.nlm.nih.gov/24500725Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial.
Neda Valizadeh, Niloufar Yahyapour Jalaly, Mohsen Hassanzadeh...
https://pubmed.ncbi.nlm.nih.gov/22430300Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis.
Adam Bobkiewicz, Wojciech Francuzik, Lukasz Krokowicz...
https://pubmed.ncbi.nlm.nih.gov/27539490Botulinum toxin for chronic anal fissure.
D Gui, E Cassetta, G Anastasio...
https://pubmed.ncbi.nlm.nih.gov/7934496Clinical Practice Guideline for the Management of Anal Fissures.
David B Stewart, Wolfgang Gaertner, Sean Glasgow...
https://pubmed.ncbi.nlm.nih.gov/27926552