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

NCT03096522 | Unknown DMC

• 1 other identifier: mansoura33
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fistula

Outcome Measures

Primary Outcomes (1)

• Healing

  Complete epithelilization of the fistulotomy wound without persistent external openings or discharge

  4-8 weeks

Study Arms (2)

Phenytoin 2% spray

ACTIVE COMPARATOR

Patients undergoing anal fistulotomy with postoperative topical phenytoin therapy

Drug: Phenytoin 2% spray; Procedure: Anal fistulotomy

Anal fistulotomy

ACTIVE COMPARATOR

Patients undergoing anal fistulotomy without postoperative topical therapy

Procedure: Anal fistulotomy

Interventions

Phenytoin 2% spray DRUG

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

Also known as: Healosol

Phenytoin 2% spray

Anal fistulotomy PROCEDURE

Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base

Also known as: Lay open of anal fistula tract

Anal fistulotomy; Phenytoin 2% spray

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Phenytoin

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sameh H Emile, M.D.

  Mansoura University, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameh Emile, M.D.

CONTACT

sameh200@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: March 30, 2017
• Study Start: February 20, 2017
• Primary Completion: January 31, 2018
• Study Completion: March 30, 2018
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)