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

Anal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096522
• Other study ID #: mansoura33
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2017
• Last updated: March 29, 2017
• Start date: February 20, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: Sameh Emile, M.D.
• Email: sameh200[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 30, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• Phenytoin 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

Procedure:
• Anal fistulotomy
Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	Complete epithelilization of the fistulotomy wound without persistent external openings or discharge	4-8 weeks