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

M

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

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

Trial contacts and locations

0

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Central trial contact

Sameh Emile, M.D.

Data sourced from clinicaltrials.gov

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