Anal Fistula
Conditions
Brief summary
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
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.
Interventions
DRUGPhenytoin 2% spray
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
PROCEDUREAnal fistulotomy
Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing | 4-8 weeks | Complete epithelilization of the fistulotomy wound without persistent external openings or discharge |
Countries
Egypt
Contacts
Primary ContactSameh Emile, M.D.
Outcome results
None listed