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The purpose of this study is to improve treatment outcomes for patients with chronic anal fissure.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main group | Experimental | Patients of the main group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) |
|
| control group | Experimental | Patients in the control group undergo excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A (40 units, injection into the internal anal sphincter at 1, 5, 7 and 11 hours, 10 units each) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| excision of the anal fissure with further relaxation of the internal sphincter with botulinum toxin A | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anal sphincter insufficiency | Frequency of anal sphincter insufficiency according to the Wexner scale | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | On day 15, 30, 45 and 60 |
| Non-Healing Wound |
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Inclusion Criteria:
Exclusion Criteria:
• Inflammatory diseases of the colon
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny E. Zharkov, MD | Contact | +79039689739 | drzharkov@mail.ru | |
| Ekaterina Yu. Lebedeva | Contact | +79779558920 | katerina.lebedeva.1997@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Sergey A. Frolov, Ph.D | State Scientific Centre of Coloproctology, Russian Federation (SSCCRussia) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SSCCRussia | Recruiting | Moscow | 123423 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8351556 | Background | Jorge JM, Wexner SD. Anorectal manometry: techniques and clinical applications. South Med J. 1993 Aug;86(8):924-31. doi: 10.1097/00007611-199308000-00016. | |
| 8416784 | Background | Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307. |
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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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
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|
Frequency of post-operative wound epithelialization
| On day 15, 30, 45, 60 |
| Profilometry /sphincterometry findings | Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry | On day 30, 60 and 365 |
| Temporary disability | Duration of temporary disability | Up to 60 days |
| Relap | Frequency of relapses | Up to 60 days |
| 22336789 | Background | Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3. |
| 10528760 | Background | Zetterstrom J, Mellgren A, Jensen LL, Wong WD, Kim DG, Lowry AC, Madoff RD, Congilosi SM. Effect of delivery on anal sphincter morphology and function. Dis Colon Rectum. 1999 Oct;42(10):1253-60. doi: 10.1007/BF02234209. |
| 1511644 | Background | Delechenaut P, Leroi AM, Weber J, Touchais JY, Czernichow P, Denis P. Relationship between clinical symptoms of anal incontinence and the results of anorectal manometry. Dis Colon Rectum. 1992 Sep;35(9):847-9. doi: 10.1007/BF02047871. |
| 24500725 | Background | Chen HL, Woo XB, Wang HS, Lin YJ, Luo HX, Chen YH, Chen CQ, Peng JS. Botulinum toxin injection versus lateral internal sphincterotomy for chronic anal fissure: a meta-analysis of randomized control trials. Tech Coloproctol. 2014 Aug;18(8):693-8. doi: 10.1007/s10151-014-1121-4. Epub 2014 Feb 6. |
| 22430300 | Background | Valizadeh N, Jalaly NY, Hassanzadeh M, Kamani F, Dadvar Z, Azizi S, Salehimarzijarani B. Botulinum toxin injection versus lateral internal sphincterotomy for the treatment of chronic anal fissure: randomized prospective controlled trial. Langenbecks Arch Surg. 2012 Oct;397(7):1093-8. doi: 10.1007/s00423-012-0948-2. Epub 2012 Mar 20. |
| 27539490 | Background | Bobkiewicz A, Francuzik W, Krokowicz L, Studniarek A, Ledwosinski W, Paszkowski J, Drews M, Banasiewicz T. Botulinum Toxin Injection for Treatment of Chronic Anal Fissure: Is There Any Dose-Dependent Efficiency? A Meta-Analysis. World J Surg. 2016 Dec;40(12):3064-3072. doi: 10.1007/s00268-016-3693-9. |
| 7934496 | Background | Gui D, Cassetta E, Anastasio G, Bentivoglio AR, Maria G, Albanese A. Botulinum toxin for chronic anal fissure. Lancet. 1994 Oct 22;344(8930):1127-8. doi: 10.1016/s0140-6736(94)90633-5. |
| 27926552 | Background | Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available. |
| D004066 |
| Digestive System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |