Chronic Anal Fissure
Conditions
Keywords
Fissure in Ano, Anal fissure, botulinum toxin A, Chronic anal pain, Fecal incontinence, Spasm of the internal sphincter, Anal sphincter insufficiency
Brief summary
The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
Detailed description
A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and ablebodied adults, so the issue of treatment is of particular relevance. The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy. All the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. However, the optimal method has not yet been developed. Non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). In particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early postoperative period. Botulinum Toxin Type A application in treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence)
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
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment. Comparative, randomized, prospective, single-center. clinical trial. Patients in the main group undergo excision of the fissure in combination with injection into internal sphincter Botulinum toxin type A In the control group, excision of the fissure was performed in combination with injection into internal sphincter Botulinum toxin type A with excision in combination with platelet rich plasma
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Patients with chronic anal fissure with spasm of anal sphincter
Exclusion criteria
* • 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anal sphincter insufficiency | 60 days | Frequency of anal sphincter insufficiency according to the Wexner scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temporary disability | Up to 60 days | Duration of temporary disability |
| 2-item pain intensity (P2) | On day 15, 30, 45 and 60 | 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 | On day 15, 30, 45, 60 | Frequency of post-operative wound epithelialization |
| Profilometry /sphincterometry findings | On day 30, 60 and 365 | Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry |
| Relap | Up to 60 days | Frequency of relapses |
Countries
Russia
Contacts
Primary ContactEvgeny E. Zharkov, MD
Backup ContactEkaterina Yu. Lebedeva
Outcome results
None listed