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| Name | Class |
|---|---|
| St. Petersburg State Pavlov Medical University | OTHER |
| Astrakhan State Medical University | OTHER |
| Siberian State Medical University | OTHER |
| City Clinical Hospital №24, Department of Health City of Moscow |
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This study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.
Chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. This condition is attended by severe pain syndrome during and after bowel movement (defecation). This condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance.
The main cause of chronic anal fissure development is spasm of the internal sphincter. It should be eliminated in the first instance, in order to provide the 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 post-operative period.
Botulinum Toxin Type A application in complex 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 |
|---|---|---|---|
| Xeomin | Experimental | Complex treatment of chronic anal fissure with drug-induced relaxation of the internal sphincter with Botulinum Toxin Type A. (IncobotulinumtoxinA 50 U Intramuscular Powder for Solution). |
|
| Xeomin control | Active Comparator | Complex treatment of chronic anal fissure with lateral subcutaneous sphincterotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA 50 U Intramuscular Powder for Solution | Drug | Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation. After that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Anal sphincter insufficiency | Frequency of anal sphincter insufficiency according to the Wexner scale incontinence after the surgical intervention. Self reported daily meausure outcome, wich evaluate from 0 - to 20 points (where 0 points = full feacal continence; 20 points = full feacal incontinence). | Up to 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 7, 30 and 60 |
| Non-Healing Wound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny E. Zharkov, MD | Contact | 89039689739 | drzharkov@mail.ru | |
| Roman Yu. Khryukin, MD | Contact | +79161598059 | texnik.lip@yandex.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 |
|---|---|---|---|---|---|---|
| GBUZ MO "Lvovskaia Raionaia Bolnica" | Recruiting | Podolsk | Moscow Oblast | 142155 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 1582352 | Background | Sohn N, Eisenberg MM, Weinstein MA, Lugo RN, Ader J. Precise anorectal sphincter dilatation--its role in the therapy of anal fissures. Dis Colon Rectum. 1992 Apr;35(4):322-7. doi: 10.1007/BF02048108. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2022 | May 4, 2022 | 8 |
| 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 |
|---|---|
| C545476 | incobotulinumtoxinA |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| OTHER_GOV |
| GBUZ MO "Lvovskaia Raionaia Bolnica" | OTHER_GOV |
| Medical Center ON-CLINIC | UNKNOWN |
A multicenter, prospective, randomized, controlled clinical study. Surgical removal of anal fissure followed by internal sphincter relaxation with Botulinum toxin type A is performed in the study group.
Lateral subcutaneous sphincterotomy to relax sphincter is a method of choice in the control group. Patients are randomized with envelope method
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| Lateral subcutaneous sphincterotomy. | Procedure | The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge. |
|
Frequency of post-operative wound epithelialization
| On day 60 |
| Profilometry /sphincterometry findings | Internal sphincter spasm or local internal sphincter spasm by the data of anorectal profilometry / or anorectal sphincterometry | On day 30 and 60 |
| Temporary disability | Duration of temporary disability | Up to 60 days |
| Relap | Frequency of relapses | Up to 60 days |
| Astrakhan State Medical University | Recruiting | Astrakhan | Russia |
|
| Medical Center ON-CLINIC | Recruiting | Moscow | 119034 | Russia |
|
| SSCCRussia | Recruiting | Moscow | 123423 | Russia |
|
| City Clinical Hospital №24, Department of Health City of Moscow | Recruiting | Moscow | Russia |
|
| St. Petersburg State Pavlov Medical University | Recruiting | Saint Petersburg | Russia |
|
| Siberian State Medical University | Recruiting | Tomsk | Russia |
|
| 18080713 | Background | Renzi A, Izzo D, Di Sarno G, Talento P, Torelli F, Izzo G, Di Martino N. Clinical, manometric, and ultrasonographic results of pneumatic balloon dilatation vs. lateral internal sphincterotomy for chronic anal fissure: a prospective, randomized, controlled trial. Dis Colon Rectum. 2008 Jan;51(1):121-7. doi: 10.1007/s10350-007-9162-7. Epub 2007 Dec 15. |
| 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. |
| Background | Khan M.I., Khan H., Khan A.U., et. al. Comparing the efficacy of botulinum toxin injection and lateral internal sphincterotomy for chronic anal fissure. KJMS, 2016. 9(1): p. 6 |
| 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. |
| 20703472 | Background | Nasr M, Ezzat H, Elsebae M. Botulinum toxin injection versus lateral internal sphincterotomy in the treatment of chronic anal fissure: a randomized controlled trial. World J Surg. 2010 Nov;34(11):2730-4. doi: 10.1007/s00268-010-0736-5. |
| 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. |
| 22869534 | Background | Magdy A, El Nakeeb A, Fouda el Y, Youssef M, Farid M. Comparative study of conventional lateral internal sphincterotomy, V-Y anoplasty, and tailored lateral internal sphincterotomy with V-Y anoplasty in the treatment of chronic anal fissure. J Gastrointest Surg. 2012 Oct;16(10):1955-62. doi: 10.1007/s11605-012-1984-5. Epub 2012 Aug 7. |
| 16091912 | Background | Katsinelos P, Papaziogas B, Koutelidakis I, Paroutoglou G, Dimiropoulos S, Souparis A, Atmatzidis K. Topical 0.5% nifedipine vs. lateral internal sphincterotomy for the treatment of chronic anal fissure: long-term follow-up. Int J Colorectal Dis. 2006 Mar;21(2):179-83. doi: 10.1007/s00384-005-0766-x. Epub 2005 Aug 10. |
| 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. |
| Background | Bagrasaryan LS, Surgical treatment of anal fissure with anal sphincter pneumodivulsion. 2010: p. 115 |
| 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. |
| 14719148 | Background | Hyman N. Incontinence after lateral internal sphincterotomy: a prospective study and quality of life assessment. Dis Colon Rectum. 2004 Jan;47(1):35-8. doi: 10.1007/s10350-003-0002-0. Epub 2004 Jan 14. |
| 8247054 | Background | Sultan AH, Kamm MA, Hudson CN, Thomas JM, Bartram CI. Anal-sphincter disruption during vaginal delivery. N Engl J Med. 1993 Dec 23;329(26):1905-11. doi: 10.1056/NEJM199312233292601. |
| 11552935 | Background | Tjandra JJ, Han WR, Ooi BS, Nagesh A, Thorne M. Faecal incontinence after lateral internal sphincterotomy is often associated with coexisting occult sphincter defects: a study using endoanal ultrasonography. ANZ J Surg. 2001 Oct;71(10):598-602. doi: 10.1046/j.1445-2197.2001.02211.x. |
| 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. |
| 2736353 | Background | Khubchandani IT, Reed JF. Sequelae of internal sphincterotomy for chronic fissure in ano. Br J Surg. 1989 May;76(5):431-4. doi: 10.1002/bjs.1800760504. |
| Background | Zbar A., M. Aslam, and V. Allgar, Faecal incontinence after internal sphincterotomy for anal fissure. Techniques in Coloproctology, 2000. 4(1): p. 25-28. |
| Background | Zharkov, EE, Comprehensive treatment of chronic anal fissure. 2009: p. 126. |
| 15972045 | Background | Iswariah H, Stephens J, Rieger N, Rodda D, Hewett P. Randomized prospective controlled trial of lateral internal sphincterotomy versus injection of botulinum toxin for the treatment of idiopathic fissure in ano. ANZ J Surg. 2005 Jul;75(7):553-5. doi: 10.1111/j.1445-2197.2005.03427.x. |
| 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. |
| 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. |
| 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. |
| D004066 |
| Digestive System Diseases |