Randomized Trial on the Effect of Topical Phenytoin on Healing After Fistulotomy

Study Overview
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Brief Summary
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Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment.

Detailed Description
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Patients with anal fistula who will undergo anal fistulotomy will be randomized into one of two groups; the first group will receive topical phenytoin therapy postoperatively and the second group will not receive such topical treatment. Healing of the wound after fistulotomy will be observed every week and the duration till complete healing will be recorded. The two groups will be compared regarding the mean duration till complete healing and postoperative complications.

Official Title
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A Randomized Controlled Trial on the Effect of Topical Phenytoin 2% on Wound Healing After Fistulotomy

Conditions
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Anal Fistula

Intervention / Treatment
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* Drug: Phenytoin 2% spray
* Procedure: Anal fistulotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders aging between 18-65 years with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers) Exclusion Criteria: Patients with high trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary, or recurrent anal fistulas. Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, and inflammatory bowel diseases. Patients under chronic corticosteriod or immunosuppressive therapy.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenytoin 2% spray<br>Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy | Drug: Phenytoin 2% spray<br>* Patients will undergo anal fistulotomy then they will use phenytoin 2% spray topically on the anal wound resulting from fistulotomy with each sitz bath (twice per day) untill the anal wound heals completely<br>* Other names: Healosol;Procedure: Anal fistulotomy<br>* Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base<br>* Other names: Lay open of anal fistula tract;|
| Active Comparator: Anal fistulotomy<br>Patients undergoing anal fistulotomy without postoperative topical therapy | Procedure: Anal fistulotomy<br>* Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base<br>* Other names: Lay open of anal fistula tract;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | Complete epithelilization of the fistulotomy wound without persistent external openings or discharge | 4-8 weeks |