Fissure in Ano
Conditions
Keywords
Fissure, botulinum toxin, Gtn ointment
Brief summary
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
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
Interventions
PROCEDUREBotulinum injection
Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application
DRUGGTN OINTMENT
0.2%GTN applied on anal canal.
Sponsors
Pak Emirates Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of fissure | Within 6 weeks | 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. |
Countries
Pakistan
Contacts
Primary ContactMubashra Badar
Outcome results
None listed