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

Mansoura University

Status: Unknown

Conditions: Anal Fistula

Treatments: Drug: Phenytoin 2% spray; Procedure: Anal fistulotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03096522

mansoura33

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

Phenytoin 2% spray

Active Comparator group

Description:

Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy

Treatment:

Procedure: Anal fistulotomy

Drug: Phenytoin 2% spray

Anal fistulotomy

Active Comparator group

Description:

Patients undergoing anal fistulotomy without postoperative topical therapy

Treatment:

Procedure: Anal fistulotomy