Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure

Study Overview
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Brief Summary
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Patients will be randomized to receive treatment with either a total of 20 U of botulinum toxin(diluted in saline to a concentration of 50 U per milliliter.

Detailed Description
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Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery

Official Title
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A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial

Conditions
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Fissure in Ano

Intervention / Treatment
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* Procedure: Botulinum injection
* Drug: GTN OINTMENT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months. Exclusion Criteria: Patients with acute fissure fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer) those who had undergone previous surgical procedures in the anal canal. known hypersensitivity to component of the formulations of type A BTX pregnant or breast-feeding women 6-refusal of consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum group<br>The internal anal sphincter to be palpated and injected with a 27-gauge needle while the patient lying on his or her left side. Each patient will receive 0.4 ml of solution containing botulinum toxin (for a total of 20 U), administered as two injections of equal volume (0.2 ml), one on each side of the anterior midline of the internal anal sphincter. No sedation or local anesthesia to be used during the procedure) | Procedure: Botulinum injection<br>* Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application<br>* Other names: Botox inj;|
| Active Comparator: GTN group<br>0.2 percent nitroglycerin ointment applied twice daily for six weeks. | Drug: GTN OINTMENT<br>* 0.2%GTN applied on anal canal.<br>* Other names: 0. 2% GTN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing of fissure | All the patients will undergo a pretreatment evaluation that will include clinical inspection of the fissure based on evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter and symptoms including post-defecatory or nocturnal pain, bleeding, or both. Then they will be randomized to receive treatment with either botulinum toxin or 0.2 percent nitroglycerin ointment applied twice daily for six weeks. The outcome in each group will be evaluated clinically.The end point of the study would be complete healing after treatment. The treatment will be considered successful if the fissure healed. Persistence of the fissure in the absence of symptoms will be considered as symptomatic improvement.The Secondary endpoints will measurement of post defecatory pain on Visual analogue scale (VAS) at each visit. | Within 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fissure, botulinum toxin, Gtn ointment