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

Pak Emirates Military Hospital

Status: Enrolling

Conditions: Fissure in Ano

Treatments: Drug: GTN OINTMENT; Procedure: Botulinum injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05590520

FIS 1cpsp

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Botulinum group

Experimental group

Description:

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)

Treatment:

Procedure: Botulinum injection

GTN group

Active Comparator group

Description:

0.2 percent nitroglycerin ointment applied twice daily for six weeks.

Treatment:

Drug: GTN OINTMENT