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

Not Applicable

• Conditions: Anal Fistula
• Interventions: Drug: Phenytoin 2% spray; Procedure: Anal fistulotomy

• Registration Number: NCT03096522
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2017-02-20
• Status Verified: 2017-03
• Study First Submitted: 2017-03-26
• Study First Submitted QC: 2017-03-26
• Last Update Submitted: 2017-03-29
• Study First Posted: 2017-03-30
• Last Update Posted: 2017-03-31
• Primary Completion: 2018-01-31
• Study Completion: 2018-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenytoin 2% spray	Anal fistulotomy	Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
Phenytoin 2% spray	Phenytoin 2% spray	Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy
Anal fistulotomy	Anal fistulotomy	Patients undergoing anal fistulotomy without postoperative topical therapy

Primary Outcome Measures

Name	Time	Method
Healing	4-8 weeks	Complete epithelilization of the fistulotomy wound without persistent external openings or discharge

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansoura, Dakahlia, Egypt